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Tag Archives: drugs
FDA & NIH Launch Electronic Safety Reporting Portal
Biology will relate every human gene to the genes of other animals and bacteria, to this great chain of being. – Walter Gilbert The FDA and the NIH have announced a joint venture called the Safety Reporting Portal (SRP). The … Continue reading
Posted in FDA, Industry News
Tagged adverse events, clinical trials, drugs, FDA, human gene transfer, IND, NIH, pharmacovigilance, safety
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FDA Ups the Ante on Transparency
Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s … Continue reading
Posted in FDA, Industry News
Tagged 510(k), ANADA, ANDA, biologics, BLA, drugs, exclusivity, FDA, medical devices, NADA, NDA, patent, PMA, transparency
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