Karyopharm Therapeutics Inc. is proud to announce the FDA approval of their lead XPO1 inhibitor compound to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). To learn more about this recent approval, please see the full press release here. (For XPOVIO®(selinexor) full Prescribing Information please visit: XPOVIO Full Prescribing Information.)
The FLASCO leadership is pleased to acknowledge Incyte Corporation as a FLASCO Diamond Corporate Member for 2020. Please welcome and THANK them for their support, when they call or e-mail you. Incyte is grounded in the rigorous pursuit of scientific excellence and driven to advance medical research to discover, develop and deliver novel medicines that…
Hello, At Genentech, we recognize that the COVID-19 national public health emergency is causing personal and financial challenges for many patients and their families. Getting their prescribed Genentech medicines shouldn’t be one of those challenges. Our highest priority is the health and safety of patients, and we believe it is critical for them to continue…
On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMOTM, Eli Lilly and Company) for the following indications: Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;…
Food and Drug Administration expanded the indication of olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination…
Register for a Live Webcast scheduled for Thursday, April 30, 2020 (several times available)! Featuring key insights from Joseph Mikhael, MD and Kenneth Shain, MD, PhD on relapsed and refractory multiple myeloma, OncLive®’s new broadcast will provide you with updates regarding management with SARCLISA. CLICK HERE Shared by Sanofi Genzyme.
In response to the COVID-19 pandemic, National Comprehensive Cancer Network® (NCCN®) has released recommendations for the use of hematopoietic growth factors during this time. The recommendations have been posted on NCCN’s website, along with other COVID-19 Resources: Hematopoietic Growth Factors Recommendations NCCN COVID-19 Resources NCCN noted that for acute myeloid leukemia (AML) and myelodysplastic syndromes…
Food and Drug Administration approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC). More Information. April 15, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-low-grade-upper-tract-urothelial-cancer Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
Help for some of the Floridian patients who have newly diagnosed cancer or progressing cancer right now. Guardant Health COVID-19 Services Blank Requisition Form
From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…
Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis…
From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…
Sandoz will be hosting a webinar March 25th at 11am ET with a Professor/Hospital Director from Italy to facilitate sharing of knowledge and clinical experience regarding the COVID-19 pandemic. Details are listed below. .
Dear Colleagues: Please take three minutes of your time to answer these important questions: https://www.surveymonkey.com/r/C8ZDYNW about the impact of the current COVID-19 pandemic on our practices, needs, and available resources. This survey has been prepared by the multi-state and international cardio-oncology collaborative network from the American College of Cardiology (ACC), American Society of Clinical Oncology (ASCO) and…
Great news! Puma Biotechnology received U.S. FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer. The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens. Adam M….
RxVantage As the COVID-19 pandemic continues to evolve, we have fielded thousands of inquiries from our medical office community about updating and communicating protocols for industry reps and vendors. What we thought was a nice-to-have feature of our free service has become mission-critical for practice communication overnight. Given the volume of inquiries we are receiving,…
After 15 years of hospital-based heme/onc practice, Dr. Steve Fein started Heme Onc Call to service hospitals that have little or no heme/onc consultant availability. Dr. Fein has a deep-seated passion for helping patients with both nonmalignant blood disorders and blood cancers, and has come to realize that all hospitals need inpatient heme/onc specialty care….
Florida Cancer Specialists Expanding Cancer Care Treatment Services & Opening First of its KindDrug Development Unit with Sarah Cannon Research Institute in Central Florida FCS’s New Lake Mary Cancer Center & Sarah Cannon Research Institute Drug Development Unit to open this month Fort Myers, Fla., February 19, 2020 — Florida Cancer Specialists & Research Institute (FCS)…
On behalf of OncLive and Dr. Lonial of Winship Cancer Institute we would to invite you to participate in “Toxicity Management in Multiple Myeloma: An OncLive Scientific Interchange and Workshop”. This 3-hour meeting will be used to share your valuable insights, expert knowledge, and practical experience on management of toxicities associated with novel therapies in the treatment…
Personalized billing and payment platform will enable an improved financial experience for oncology patients across the growing FCS community-based provider network Fort Myers, Fla., February 10, 2020 — Florida Cancer Specialists & Research Institute (FCS) and Cedar, a patient engagement and payment technology platform, today announced that they are partnering to modernize the on-line payment experience…
On behalf of Taiho Oncology, Inc., we are pleased to inform you that a corporate press release, “Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML” has been issued…
Epizyme announces that U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK (tazemetostat) for the treatment of adults and pediatric patients age 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for resection, based on overall response rate and duration of response in a Phase 2 clinical trial. You…
Merck is pleased to announce that KEYTRUDA® (pembrolizumab) has been approved by the FDA for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. PD-L1 diagnostic testing is not…
Today, the U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet…
https://www.janssencarepath.com/hcp/general-resources Access support to help navigate payer processes Know Your State Interactive Tool — Provides information on affordability options for your patients at the state level. Supporting Appropriate Payer Coverage Decisions Brochure — Helps you understand the information that payers may require for your patient’s coverage of medically necessary drug therapies. Prior Authorization Considerations Checklist — Presents general information…
Merck and FLASCO share the ASCO triple aim of matching the right patient to the right drug at the right time and believe this project can further that objective. Merck/AstraZeneca developed and shared a non-branded electronic resource that can be utilized by providers and patients, in both English and Spanish, that highlights why BRCA testing…
Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach…
Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. More Information. January 8, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer Hematology/Oncology (Cancer)…
From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…
Genentech is pleased to inform you that the Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code for POLIVY™ (polatuzumab vedotin-piiq). POLIVY received FDA approval on June 10, 2019. Effective January 1, 2020, the J-code is J9309 (Injection, polatuzumab vedotin-piiq, 1 mg). The POLIVY J-code Announcement Flash Card, which details the new…
The PDF below contains sample coding information. Please see full Prescribing Information. Please feel free to contact the Genentech team with any questions or concerns about coding and billing. Contact a POLIVY Access Solutions Specialist at (888) 249-4918 Monday through Friday, 6 a.m. to 5 p.m. PT, or visit Genentech-Access.com/POLIVY. Correct coding is the responsibility of…
WHAT IS PADCEV? PADCEV (enfortumab vedotin-ejfv) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you have received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine….
Starting January 1,2020, the Lonsurf Copay Assistance Program will transition to a new copay administrator. It will require some administrative actions on the part of whomever processes the scripts, both refills of existing scripts and new scripts. Currently enrolled, commercially insured eligible patients will move to the new program: Member ID # will remain…
FDA approved enzalutamide (XTANDI, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC). More Information. December 16, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-metastatic-castration-sensitive-prostate-cancer Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications
Edgardo S. Santos Castillero, M.D., FACP, Secretary of the Florida Society of Clinical Oncology (FLASCO), Founding Partner, Florida Precision Oncology R&C, FPO, a Division of 21st Century Oncology Thoracic and Head/Neck Cancer Programs, and Clinical Associate Professor at Charles E. Schmidt College of Medicine, Florida Atlantic University shared his appreciation of the opportunity provided by ASCO to him and his Co-Chairs…
Luis E. Raez, MD, FACP, FCCP, President of Florida Society of Clinical Oncology (FLASCO), Chief Scientific Officer & Medical Director of Memorial Cancer Institute, Memorial Health Care System and Clinical Professor of Medicine at the Herbert Wertheim College of Medicine, Florida International University participated in the Expert Panel created by the American Society of Clinical Oncology (ASCO) and the National Community Oncology Dispensing…
Please be aware NCCN has recently updated their Oncology Guidelines for Mantel Cell Leukemia (MCL) based on the accelerated approval for BRUKINSA. NCCN has provided BRUKINSA (zanubrutinib) in R/R MCL with a Level 2A Preferred evidence listing, comparable to other BTKi in the class. This is the link to the NCCN main website, https://www.nccn.org/professionals/physician_gls/default.aspx .
Signatera is a personalized, tumor informed circulating tumor DNA (ctDNA) test for molecular residual disease (MRD) assessment and surveillance monitoring. Signatera’s unique assay design is optimized to detect low levels of ctDNA with high sensitivity and specificity earlier than current colorectal cancer (CRC) standard of care. Signatera recently received Medicare draft coverage for certain forms…
In July 2019, the FLASCO Board of Directors approved a Survey Initiative on BRCA testing with Merck, FLASCO Diamond Elite Member. All FLASCO Members who treat patients with breast/ovarian cancer, including APPs, were asked to complete the survey. The goal of the project was to identify the needs in order to increase awareness and utilization…
Today, the U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older. Common side effects for patients taking…
The US Food and Drug Administration has recently approved REBLOZYL® (luspatercept-aamt), the first and only erythroid maturation agent (EMA) indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require…
Sandoz Inc., a division of Novartis, is pleased to announce that Sandoz Inc. has received FDA approval for ZIEXTENZO (pegfilgrastim-bmez). As you may be aware, ZIEXTENZO, a biosimilar of Neulasta®, is a long-acting G-CSF indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs…
As part of Genentech’s ongoing commitment to patient access and ensuring that patients and practices have a positive experience with Genentech, we constantly assess our processes to ensure they remain in the best interest of our practices and patients. Starting October 21st 2019, we will be launching a faster, more intuitive Genentech Patient Foundation enrollment…
October 18, 2019 at 7:45 PM EDT PDF Version – At 26 weeks, 54% of adults and 71% of children treated with ULTOMIRIS demonstrated Complete Thrombotic Microangiopathy (TMA) Response – BOSTON–(BUSINESS WIRE)–Oct. 18, 2019– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (FDA) approved ULTOMIRIS® (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS)…
Board approves increase in annual grant amount Sarasota, Fla., Oct. 17, 2019 — Since its inception in 2011, the Florida Cancer Specialists (FCS) Foundation has provided over $5.5 million in grants to help cancer patients in need. The FCS Foundation has awarded $1.16 million in grants year-to-date in 2019, surpassing the prior year’s total. The FCS…
Genentech Access Solutions – Medicare Beneficiary Identifier (MBI) Update This PDF provides important information about The Centers for Medicare & Medicaid (CMS) transition from the use of the Health Insurance Claim Number (HICN) to a Medicare Beneficiary Identifier (MBI) number, and how Genentech Access Solutions is addressing this conversion. Beginning January 1, 2020, Genentech Access…
Recently, the Centers for Medicare and Medicaid Services (CMS) posted two announcements which impacts payment and coverage for Chimeric Antigen Receptor T-Cell (CAR T) Therapies. This email will provide a brief summary of the Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) Final Rule, and the National Coverage Determination (NCD) for CAR T cell therapy…
Centers for Medicare & Medicaid Services (CMS) has made a change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code and has assigned a permanent J-code. Effective July 1, 2019 the permanent J-code for Herceptin HYLECTA is J9356. If you have any questions, please reach out to me directly. You may also call Genentech Access Solutions at…
There was a recent update to the TECENTRIQ (atezolizumab) Prescribing Information that impacted the dosing regimens for certain indications. This change would allow for either the 840 mg or 1200 mg vials to be used for those indications. Please see below for the NDC information. Updated Prescribing Information Urothelial Carcinoma o Administer TECENTRIQ as: 840…
Verastem Cares is a comprehensive, personalized program designed to provide information and assistance to patients who have been prescribed our medicines. To learn more about Verastem Cares, contact us at 1-833-570-CARE (2273). Here is the website of Verastem Cares: https://www.verastem.com/patients/verastemcares/
The FDA granted accelerated approval to Polivy™, Genentech’s fifth blood cancer medicine. Polivy (polatuzumab vedotin-piiq) is a first-of-its-kind anti-CD79b antibody-drug conjugate used in combination with bendamustine plus Rituxan (rituximab) for people with diffuse large B-cell lymphoma (DLBCL) whose disease returned after or did not respond to multiple treatment regimens. The Genentech press release including Important…
Don Champlain Memorial Fund In Loving Memory of Don Champlain In lieu of flowers, donations can be made to the Don Champlain Memorial Fund, benefiting the Florida Cancer Specialists Foundation. Don had an incredible outlook and contagious positivity. His passion for his job was compelling and he leaves behind a legacy of love, dedication and…
The Centers for Medicare and Medicaid Services (“CMS”) announced a final rule permitting Medicare Part B plans, including those administered through Medicare Advantage, to impose step therapy on new starts of Part B drugs. CMS noted that this utilization management tool will “ensure that Medicare beneficiaries pay less overall … for Part B drugs.” CMS…
On May 15, 2019, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). VENCLEXTA is also approved in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia…
New Medical Oncologist Joins in Palm Beach County Fort Myers, FL – June 4, 2019 . . . Florida Cancer Specialists & Research Institute (FCS) is pleased to announce that Medical Oncologist and Hematologist, Barry S. Berman, MD has joined joined the statewide practice and will be seeing patients in two offices, including West Palm Beach (1309…
EMD Serono is pleased to announce that on May 14, 2019 the U.S. Food and Drug Administration (FDA) approved BAVENCIO® (avelumab) Injection 20 mg/mL for a new indication, which is in combination with axitinib. BAVENCIO is co-developed and co-commercialized by EMD Serono and Pfizer Inc, and axitinib is commercialized by Pfizer Inc. The following information…
Apr 12, 2019 United States — BALVERSA is the first FGFR kinase inhibitor to receive U.S. FDA approval — Simultaneous approval of companion diagnostic intended to identify a subset of patients most likely to benefit from BALVERSA, offering a personalized treatment approach HORSHAM, Pa., April 12, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced…
Up to $2,500 will be awarded to a deserving PA student with a strong interest in pursuing a career in oncology Must be an AAPA member (or applicant) and enrolled in a ARC-PA-accredited program Minimum GPA is 3.0 (or PASS/FAIL equivalent) For a comprehensive list of eligibility criteria, please see visit the APAO website. Deadline: May…
Enriching Communication Skills for Health Professionals in Oncofertility (ECHO) is a free web-based training program focusing on building communication skills. Training Topics include: Risk of infertility Fertility preservation Sexual functioning Body image Ethical, social, and cultural considerations Interested learners should submit their application on our website at: https://echo.rhoinstitute.org/2020-echo-application/. Deadline to apply is November 22nd, 2019….
Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC). PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients FDA=Food and Drug Administration; PD-L1=programmed death ligand 1. Selected Safety Information…
Effective June 1 or October 1, 2019, (based on your contract) UnitedHealthcare will no longer reimburse Current Procedural Terminology (CPT) Consultation Codes 99241 to 99255 when billed by any health care professional or medical practice. For detailed information about the updated policy, please review page 20 of the March 2019 edition of the UnitedHealthcare Network…
Genentech is excited to share the news of a new FDA-approved therapy. Adjuvant Breast Cancer HERCEPTIN HYLECTATM (trastuzumab and hyaluronidase-oysk) is indicated for adjuvant treatment of adults with HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer: As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel With docetaxel and…
The Oncotype DX AR-V7 Nucleus Detect® Assay is the first and only nuclear-localized AR-V7 liquid biopsy blood test that can help guide treatment decisions for patients diagnosed with mCRPC who have received and failed an AR-targeted therapy such as XTANDI® (enzalutamide), ZYTIGA® (abiraterone), or ERLEADA™ (apalutamide). The Oncotype DX AR-V7 Nucleus Detect test can help…
Genentech is excited to share the news of a new FDA-approved indication. TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line (1L) treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Please see the attached TECENTRIQ 1L SCLC Day 1 Letter, as well as the TECENTRIQ full Prescribing Information, for…
The FDA approved Tecentriq (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of adults with extensive-stage small lung cancer (ES-SCLC). It is the first new initial treatment option approved by the FDA for people with ES-SCLC in more than 20 years. The Genentech press release including Important Safety Information is…
National Comprehensive Cancer Network© (NCCN©) has updated the Clinical Practice Guidelines in Oncology for Colon and Rectal Cancer to include BRAFTOVI® in combination with MEKTOVI® and cetuximab or panitumumab as a Category 2a treatment for patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC), after failure of one to two prior lines of therapy for metastatic disease….
On February 23, 2019, the U.S. Food and Drug Administration approved LONSURF® (trifluridine and tipiracil) tablets for metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. 1LONSURF is also indicated for…
– First medicine approved in the U.S. specifically for the treatment of aTTP, a rare blood-clotting disorder – Cablivi is the first U.S. approval for Sanofi’s new rare blood disorders franchise BRIDGEWATER, N.J., Feb. 6, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the…
Nation’s Largest Independent Hematology/Oncology Practice Reflects On More Than Three Decades of Advances in Cancer Care Fort Myers, FL – February 25, 2019. . . In February of 1984, Dr. William Harwin, Founder and President Emeritus of Florida Cancer Specialists & Research Institute (FCS), could only dream of what his fledgling community oncology/hematology practice might become…
View our Medicare coverage press release here. For more info about clonoSEQ, including test limitations, read the Technical Summary here. ABOUT ADAPTIVE BIOTECHNOLOGIES As a pioneer and leader in the field of immunosequencing, Adaptive Biotechnologies combines next generation sequencing (NGS) and proprietary bioinformatics to profile T-cell and B-cell receptors to drive groundbreaking research in cancer and other…
Press Release See All Press Releases Sign up for Email Alerts Press Release RSS Sprycel is the first and only second-generation tyrosine kinase inhibitor for pediatric patients for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy Approval marks second pediatric leukemia indication for Sprycel 1 CATEGORY: CORPORATE/FINANCIAL NEWSWEDNESDAY, JANUARY 2, 2019 4:25 PM EST#FDA…
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