What's New on the FDA Drugs Site
December 16, 2016
- CDER Statement: FDA proposes six bulk drug substances for inclusion on the 503A bulks list
- FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings
- CDER Statement: FDA working with manufacturers to resolve challenges with the Clozapine REMS Program (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Shortages
- Procainamide Hydrochloride Injection, USP (Updated - Currently in Shortage)
- National Drug Code Directory
- List of Determinations Including Written Request (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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