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March 5, 2021

Why You Should Not Use Ivermectin to Treat or Prevent COVID-19

Image COVID-19. We’ve been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it’s perhaps […]
March 4, 2021

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research FDA plays a critical role in […]
March 4, 2021

SafaLab, Inc. – 611233 – 02/18/2021

Product: DrugsFood & Beverages WARNING LETTER Date: February 18, 2021 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you […]
March 4, 2021

FDA approves lorlatinib for metastatic ALK-positive NSCLC

On March 3, 2021, the Food and Drug Administration granted regular approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with metastatic non-small cell lung cancer (NSCLC) […]
March 4, 2021

Real World Data / Real World Evidence RWD/RWE

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]
March 4, 2021

Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry

Docket Number: FDA-2019-D-1263 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance is intended to encourage […]
March 3, 2021

Cipher Pharmaceuticals US LLC – 460380 – 08/24/2017

Product: Drugs Recipient: Recipient Name Robert D. Tessarolo Recipient Title President and Chief Executive Officer Cipher Pharmaceuticals US LLC 440 Monticello Avenue, Suite 2200Norfolk, VA 23510United […]
March 3, 2021

Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. – 11/14/2017

Delivery Method: Facsimile Product: Drugs Recipient: Recipient Name Ira Weisberg Recipient Title President/CEO Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. 15 Benedict CrescentBasking Ridge, NJ 07920United States Issuing […]
March 3, 2021

Avanthi, Inc. – 12/19/2017

Product: Drugs Recipient: Recipient Name Vidya Vepuri Recipient Title Director Avanthi, Inc. 110 Terry Drive, Suite 100Newtown, PA 18940United States Issuing Office: The Office of Prescription […]
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