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Tag Archives: guidance
New FDA Guidances – September 2011
Here’s a list of the notable guidances released by FDA in September 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Reproductive and Developmental Toxicities – Integrating Study Results to Assess Concerns User Fee Waivers, Reductions, and Refunds for Drug … Continue reading
Posted in FDA, Regulatory Strategy
Tagged FDA, guidance, marketing, toxicology, validation
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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
New FDA Guidances Released in July 2011
Here’s a list of the guidances released by FDA in July 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device In Vitro Companion Diagnostic … Continue reading
New Guidances from FDA – June 2011
Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biologics, cancer, Cato Research, FDA, guidance, IDE, in vitro diagnostics, manufacturing, medical devices, OTC, PMA
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Recap of the DIA Annual Meeting 2011
The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, … Continue reading
Posted in Uncategorized
Tagged AIDS, biologics, biosimilar, Cato Research, CBER, CDER, clinical trials, DIA, EMA, EU, FDA, follow-on biologics, generic drugs, geriatric, GMP, guidance, HIV, marketing application, oncology, Orphan Drug Designations, pediatric, pharmacovigilance, pre-IND
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