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…
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…
The FDA cited an Indoco Remedies API facility in Goa, India, for serious quality failures and inadequate handling of complaints. Source: Drug Industry Daily
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.…
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…
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…
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. Source: International Pharmaceutical…
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks.jpg" NAME"Why This Bay Area Biotech Stock Grew 415% in the Last Year" ALT"Why This Bay Area Biotech Stock Grew 415% in the Last Year"April 12, 2017By Mark Terry,…