fbpx
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 […]
March 3, 2021

Nalpropion Pharmaceuticals LLC – 09/22/2020

Reference #: 4674240 Product: Drugs Recipient: Recipient Name George Hampton Recipient Title Chief Executive Officer Nalpropion Pharmaceuticals LLC 10 North Park PlaceSuite 201Morristown, NJ 07960United States […]
March 3, 2021

FDA’s Data Modernization Action Plan: Putting Data to Work for Public Health

Image By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs, and Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner & Acting Chief Information Officer With the […]
March 2, 2021

Coronavirus (COVID-19) Update: March 2, 2021

For Immediate Release: March 02, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
March 2, 2021

Roadmap to 2030 for New Drug Evaluation in Older Adults – 03/23/2021 – 03/23/2021

On This Page Date: March 23, 2021 Time: 10:00 AM – 4:30 PM ET Sponsored by the Office of Clinical PharmacologyOTS, CDER, U.S. Food and Drug […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0