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The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Read More
The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. Read More
The FDA finalized 48 guidances for generics manufacturers, outlining the recommended studies for demonstrating bioequivalence for dozens of active ingredients and combinations, to assist the industry with generating evidence to support ANDA approvals. Read More
The FDA revised its near-decade-old guidance on developing generic versions of digoxin tablets, calling for more robust testing. The agency reconsidered the guidance in response to a citizen petition from reference holder Concordia Pharmaceuticals. Read More
FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals. Read More
The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More
The committee’s report will assess the quality, safety and efficacy of the product, as well as examine the risk-benefit balance based on intended populations and markets. Read More
The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Read More
The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on measuring drug risks to human reproduction. Read More