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November 1, 2022

Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

Submit Comments by 01/03/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
November 1, 2022

Lupin Limited – 633703 – 09/27/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Akash Patel Recipient Title Site Head and Senior General Manager Manufacturing Lupin Limited T-142, MIDC Tarapur […]
November 1, 2022

Walmart Inc. – 631755 – 10/28/2022

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Doug McMillon Recipient Title CEO Walmart Inc. 702 SW 8th StreetBentonville, AR 72716-6299United States [email protected] Issuing Office: […]
November 1, 2022

Latin Foods Market – 631753 – 10/28/2022

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER October 28, 2022 RE: 631753 Dear […]
November 1, 2022

Amazon.com, Inc. – 631751 – 10/28/2022

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER October 28, 2022 RE: 631751 Dear […]
November 1, 2022

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, LLC – 644180 – 10/21/2022

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Lou Wood Kennedy Recipient Title CEO and Owner Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center, […]
November 1, 2022

McConnell Labs Inc. – 638958 – 10/18/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Jim McConnell Recipient Title President McConnell Labs Inc. 406 SW Umatilla Ave.Redmond, OR 97756United States Issuing […]
October 31, 2022

Recently Issued Guidance Documents

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try […]
October 31, 2022

Model-Informed Drug Development Paired Meeting Program

The FDA is conducting a Model-Informed Drug Development (MIDD) Paired Meeting Program that will build on the success of the MIDD Paired Meeting Pilot by continuing […]
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