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Australia’s drug regulatory agency is urging drugmakers to reassess their quality control and data management systems after agency officials found frequent data integrity violations during GMP inspections over the past five years 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
The Trump administration’s federal hiring freeze officially ended yesterday — but OMB Director Mick Mulvaney has warned the FDA and other federal agencies to prepare for deeper, long-term staff cuts. Read More
The FDA granted expedited review to Humacyte’s tissue therapy under the new Regenerative Medicine Advanced Therapy pathway — one of the first products to receive the designation established by the 21st Century Cures Act. Read More
The Chinese FDA is proposing to relax restrictions on imported drugs by no longer requiring that foreign drugs be approved abroad, or be in late-stage clinical trials, before an international multi-center trial can be started in China to seek an approval. Read More
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More
The EMA is recommending the European Commission suspend sales of more than 300 generic drug formulations approved using flawed bioequivalence studies conducted at two Micro Therapeutic Research Labs’ facilities in India. Read More
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices.
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