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Q4B Annex 7 (R2): Dissolution Test General Chapter
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Q4B Annex 5: Disintegration Test General Chapter
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S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology
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S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
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S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
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Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations
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Implementation of the Biologics Price Competition and Innovation Act of 2009
The Patient Protection and Affordable Care Act (PPAC Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to or “interchangeable” with an FDA-approved biological product. These new statutory…
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA investiga dos muertes tras inyección con antipsicótico de larga duración Zyprexa Relprevv (pamoato de olanzapina)
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FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy
Prescription nonsteroidal anti-inflammatory drugs (NSAIDs) and miscarriageFDA reviewed five observational studies that evaluated the risk of the spontaneous loss of a pregnancy before the 20th week with NSAID use.2-6 Miscarriage occurs in the general population at a frequency of about one in six pregnancies. Three retrospective case-control studies2-4 which included over 100,000 subjects reported a…