...by one-fourth from 1997 to the lowest level in over a decade in spite of an uptick in the number of OTC products called back from the market. The decline reflects a 50% drop in oral solid and injectable Rx recalls. Significant reductions occurred in labeling mix-ups, dissolution failures, and potency-related problems. Countering the overall downtrend for the year was a rise in recalls related to contamination, NDA/monograph non-compliance, and cGMP deficiencies. Consent decrees accompanied multi-product recalls for two drug producers and a biologics firm. [An eight-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 1998 begins on page 9.]
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The inclusion of investigational drugs in the Critical Medicines Act and new provisions on stockpiling are among the raft of amendments the European Parliament has made to the draft legislation.
A meeting between the European Commission and industry stakeholders has revealed several areas of importance and lessons learned in relation to the EU Health Technology Assessment Regulation, which began to apply to certain medicinal products this year.
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