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April 19, 2022

Genomma Lab USA, Inc. – 628381 – 04/13/2022

Product: Drugs Recipient: Recipient Name Bradley Johnson Genomma Lab USA, Inc. 4550 Post Oak Place Dr, Suite 326Houston, TX 77027-3167United States [email protected] Issuing Office: Center for […]
April 19, 2022

Skin Authority, L.L.C. – 628385 – 04/13/2022

Product: Drugs Recipient: Recipient Name Ted Hilling Skin Authority, L.L.C. 3186 Lionshead Ave Ste 150Carlsbad, CA 92010United States [email protected] Issuing Office: Center for Drug Evaluation and […]
April 18, 2022

The ABCs of Product-Specific Guidances | Audio Transcript

SBIA: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast Series Today’s topic: The ABCs of Product-Specific Guidances, otherwise knowns as PSGs. PSGs […]
April 18, 2022

Compounding Quality Center of Excellence On-demand Training

Subscribe to receive email announcements about new training. The FDA Compounding Quality Center of Excellence’s is providing anytime, anywhere training resources to support outsourcing facilities and […]
April 15, 2022

FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials – Considerations and Lessons Learned from the Changing Landscape (2022) – 03/07/2022

On This Page Date: March 7 – 9, 2022 Time: 7:30 AM – 12:00 PM ET FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and […]
April 15, 2022

Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet

Docket Number: FDA-2021-D-1238 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs Center for Biologics Evaluation and Research The Food […]
April 14, 2022

Bioavailability Studies Submitted in NDAs or INDs – General Considerations

Docket Number: FDA-2018-D-4367 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations to sponsors and applicants2 submitting bioavailability (BA) information […]
April 14, 2022

Guidance Recap Podcast | Bioavailability Studies Submitted in NDAs or INDs – General Considerations

Thank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this episode, […]
April 13, 2022

Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers – 04/13/2022

On This Page Date: April 13, 2022 Time: 2:00 PM – 4:30 PM ET [embedded content] Persons with disabilities having problems accessing the PDF file below […]
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