A filing with the FDA to gain approval of a major change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. See also CBE and CBE 30.
Glossary
Prior Approval Supplement
03.25.13
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Choosing and Managing a CDMO
Speed up your time-to-market, keep development costs under control and smooth the FDA approval and commercial launch process.Dana Toops, President, Avema Pharma Solutions
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Drug Development
Solving the Pharma Talent Crunch
Addressing talent shortages in today's pharmaceutical sectorJim Sykes, Managing Director, Pharmaceutical & Life Sciences, Alexander Mann Solutions
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Promotions & Moves
Akebia Therapeutics Names CMO
Jain to lead clinical development of the company’s HIF pipeline
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Breaking News | Drug Development | Industry News | Preclinical Outsourcing
Pierre Fabre Buys Igenica Immuno-oncology Assets
Deal reinforces Pierre Fabre’s pipeline in oncology, its primary R&D focus area
