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Tag Archives: safety
August 2011 FDA Guidances
Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading
Divisive Devices or UFC 510(k): FDA Meets IOM
In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices. This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, clinical trials, FDA, manufacturing, medical devices, PMA, postmarketing, safety
1 Comment
Free Educational Webinar – New Rules in FDA Safety Reporting: Are You Prepared?
UPDATE: The slides from the webinar are now available for download here. Please join us on Wednesday, 15 June (10:00 AM EDT) as we focus on the FDA’s new rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and … Continue reading
Posted in Clinical Trials, Webinars
Tagged adverse events, bioavailability, bioequivalence, clinical trials, FDA, guidance, IND, pharmacovigilance, safety, webinar
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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
New FDA Guidances – April 2011
Once again, Cato Research Regulatory Scientist Cathy Anderson has compiled a list of the notable guidance documents that have been recently released by the FDA. Here’s a summary of the guidances released in April 2011 (most links go directly to … Continue reading
Posted in FDA, Industry News
Tagged FDA, guidance, humanitarian device exemption, manufacturing, medical devices, PMA, safety, validation
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