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The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility ...
The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising. In 2022, the Act was updated with the FDA Modernization Act 2.0, which cancelled a 1938 mandate to require animal testing for every drug development protocol.
The 600 series covers biological products (e.g. vaccines, blood): 601 Licensing under section 351 of the Public Health Service Act; 606 et seq. cGMPs for human blood and blood products; The 700 series includes the limited regulations on cosmetics: 701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting
FDA Accepts Biogen Idec's Biologics License Application for First Long-Lasting Factor VIII Therapy for Hemophilia A -ELOCTATE ™ Has Potential to Provide Long-Lasting Protection and Markedly ...
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
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The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product.