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Tag Archives: 21 CFR
FDA Enforcement of New IND and BA/BE Safety Reporting Requirements
FDA announced at the end of March 2011 that the new IND and bioavailability/bioequivalence (BA/BE) study reporting requirements (final rule published September 29, 2010), originally effective on March 28, 2011, will not be enforced until September 28, 2011. FDA’s intent … Continue reading
Posted in Clinical Trials, FDA, Industry News
Tagged 21 CFR, adverse drug reactions, adverse events, bioavailability, bioequivalence, clinical investigator, FDA, IND, safety
1 Comment
Annual Reports: A Time for Reflection
You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year? Quite possibly. In the rush to keep things moving, it’s all too easy to not take the time … Continue reading
Posted in eCTD, FDA, Regulatory Strategy
Tagged 21 CFR, adverse events, annual report, clinical trials, CMC, drug development, eCTD, FDA, IND, nonclinical research, protocol
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DDMAC Sends Warning Letter Over Unbranded Websites
If you judge, investigate. – Seneca I know you just read the title, but let me say it again with some emphasis: DDMAC Sends Warning Letter Over Unbranded Websites. That’s right, a warning letter over websites that contained no “direct” … Continue reading
Posted in FDA, Industry News
Tagged 21 CFR, accelerated approval, advertising, CDER, clinical trials, DDMAC, FDA, first-line treatment, Gleevac, Novartis, off label promotion, oncology, unbranded websites, warning letters
2 Comments
