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 […]
October 31, 2022

Food and Drug Administration Reauthorization Act of 2017 (FDARA) Hiring Data

As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI) and the Biosimilar User Fee Act (BsUFA II), the Food and Drug […]
October 31, 2022

Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability

Docket Number: FDA-2022-D-0760 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs This guidance is intended to assist sponsors in […]
October 28, 2022

Complex Innovative Trial Design Paired Meeting Program Frequently Asked Questions

Response: The CID Paired Meeting Program is the PDUFA VII continuation of the CID Pilot Meeting Program established under the sixth iteration of the Prescription Drugs […]
October 27, 2022

FDA Responses to Action Items from October 26-27, 2021, Inter-governmental Working Meeting on Drug Compounding

FDA will work with the National Association of Boards of Pharmacy (NABP) to raise state awareness of available trainings sponsored by FDA’s Compounding Quality Center of […]
October 27, 2022

Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention

Submit Comments by 12/27/2022 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 […]
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