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January 13, 2021

Drug Master File (DMF) Submissions on New FDA Form 3938 – 01/13/2021 – 01/13/2021

On This Page Date: January 13, 2021 Time: 12:00 PM – 1:00 PM ET [embedded content] Download Slides How will eCTD format requirements and Form 3938 […]
January 13, 2021

CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of […]
January 12, 2021

Database of Pharmacogenomic Information in Ethnic Minority Populations (dbPGxEMP)

Description Differences in genes can make someone more or less likely to benefit from a drug, suffer side effects, or require a dose that is different […]
January 12, 2021

Workshop on Evaluating RWE from Observational Studies in Regulatory Decision-Making – 02/16/2021 – 02/17/2021

On This Page Date: February 16 – 17, 2021 Day1: Tue, Feb 16 1:00 PM – 5:00 PM ET Day2: Wed, Feb 17 1:00 PM – […]
January 12, 2021

Infuscience, Inc. dba Bioscrip Infusion Services – 609526 – 12/21/2020

Delivery Method: Electronic Email Product: Drugs Recipient: Recipient Name Alan Theriault Recipient Title Pharmacy Manager Infuscience, Inc. dba Bioscrip Infusion Services 4151 Lafayette Center Drive, Suite […]
January 12, 2021

Smarter Nutrition, Inc. – 610024 – 12/28/2020

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Daqing Goa Recipient Title President Smarter Nutrition, Inc. 17870 Newhope St. Suite 104-480Fountain Valley, […]
January 11, 2021

UPDATED TIME AND MEETING MATERIALS INFORMATION: October 8, 2020 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement – 10/08/2020 – 10/08/2020

On This Page Date: October 8, 2020 Time: 10:00 AM – 5:00 PM ET UPDATED INFORMATION (as of September 24, 2020): The meeting time has changed […]
January 11, 2021

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

CDER Warning Letters notify manufacturers of significant violations of FDA regulations. CDER works with the company to ensure correction.
January 11, 2021

Warning Letters 2021

Office of Prescription Drug Promotion Office of Compliance/Immediate Office  Office of Manufacturing Quality Office of Scientific Investigations Office of Unapproved Drugs and Labeling Compliance Coco’s Holistic […]
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