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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 updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More
More than a dozen pharmaceutical industry leaders agreed to work together to develop new painkillers without the harmful addictive effects of opioid medicines — and to use the NIH as a central clearinghouse for research to speed up product development. Read More
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