This Week at FDA: FDA Official Criticizes UniQure, States Eye Cheaper Drug Imports, and More
Article Summary: FDA took several notable actions this week across drugs and medical devices. In an …
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- March 12: Large Language Models for Interrogating Drug Labels
- April 15: Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers
- April 22-23: Generic Drugs Forum (GDF) 2026
- May 5: Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products
- June 2-4: FDA | MHRA | Health Canada Joint Symposium on GCP, BE and GVP
- June 8-9: Generic Drug Science and Research Initiatives Public Workshop
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This Week at FDA: Speedy Drug Review Bonuses, Makary Defends Prasad, and More
Article Summary: This week’s FDA updates focus on regulatory reforms, product approvals, and s…
FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
Today, FDA published a new batch of draft product-specific guidances (PSGs). PSGs provide recommenda…