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For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product. Read More
The European Medicines Agency Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including four orphan drugs and three biosimilars. Read More
The FDA approved Renflexis, a biosimilar of Remicade, in several indications including rheumatoid arthritis, plaque psoriasis and Crohn’s disease. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including developing a model for the agency’s future, post-Brexit. Read More
An FDA memo outlining restrictions on communications over unapproved uses could restrict the flow of important information, and conflict with a company’s freedom of speech, say drugmakers and industry groups. Read More
The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed as required in ICH Good Clinical Practice guidelines. Read More