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Novel Excipient Review Pilot Program FDA
September 08, 2021
The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program).
Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products fda.gov
July 12, 2021
Ranitidine, which blocks histamine-induced acid secretion in the stomach, was approved in 1983.
Immunogenicity Expert and FDA Alum Dr. Amy Rosenberg Joins EpiVax prnasia
July 07, 2021
EpiVax, Inc. is pleased to announce that Dr. Amy Rosenberg is leaving the FDA's Division of Therapeutic Proteins, CDER, which she led for over 20 years, to join EpiVax as Senior Director of Immunology and Protein Therapeutics.
New harmonised guidance for post-approval changes released by FDA europeanpharmaceuticalreview
May 18, 2021
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
FDA’s Office of Generic Drugs Receives Approval to Undergo Reorganization americanpharmaceuticalreview
January 15, 2021
The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the approval of the Office of Generic Drugs’ (OGD) reorganization.
CDER Conversation: Safely Using the Newly Available OTC Asthma Inhaler Primatene Mist fda
November 09, 2018
Talking with Theresa Michele, M.D., who is the director of the Division of Nonprescription Drug Products, CDER.
CDER’s Drug Therapy Approvals of 2017 FDA
February 09, 2018
Drugs designated First-in-Class and those approved to treat patients with rare diseases often have a strong positive impact on patient health.
Other Novel Drug Approvals: Advances in Patient Care Across a Broad Range of Diseases FDA
February 09, 2018
Novel drugs are often innovative products that serve previously unmet medical needs.
2017: A Year of Innovation and Advances FDA
February 09, 2018
CDER’s drug therapy approvals of 2017 will help a wide range of patients suffering from many different diseases while many new treatment options for patients in need.
46 New Drugs: The Number of New Drugs Marketed in 2017 Set a New Record for Recent 20 Years Dophine
January 03, 2018
FDA approved the marketing of 46 new drugs in total by December 21, 2017, successfully setting a new review record for the recent 20 years.