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The FDA refused to approve Cempra’s community-acquired bacterial pneumonia antibiotic Solithera, citing manufacturing and safety concerns in a complete response letter. Read More
During the coming transfer of political power, the FDA will survive major changes despite strong rhetoric and vague promises for reform, said a long-time FDA insider. Read More
To help speed the approval of generics, the FDA Friday said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Read More
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
The FDA issued a draft guidance on the preliminary request for designation process, and what information to include. The pre-RFD process provides informal, non-binding feedback on the regulatory identity or classification of a drug, biologic or combination product. Read More
The FDA issued a draft and a separate final guidance dealing with when the agency would exercise enforcement discretion for certain violations covering repackaging products. The draft addresses biologics, while the final guidance deals with drugs. Read More
The FDA responded to commonly raised questions about the 180-day exclusivity for generics in a draft guidance document covering everything from patents to forfeitures. Read More