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The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More
To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a “SWAT team” of reviewers dedicated to the task, starting with the oldest applications first. Read More
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More
For the next generation of the FDA’s biosimilar user fee program, the agency is proposing a new model for reviewing 351(k) applications — allowing for additional communication between review teams and sponsors through development meetings across the submission timeline. Read More