...include a surge in Class I-rated actions. Altogether, 27 drug products were recalled that were judged to pose a serious health threat, about two-thirds of which were contaminated. Several contamination-related recalls listed by FDA during the year were associated with FDA inspection findings of significant GMP deviations, including a Class I action involving nine injectable products by a pharmacy compounder. Agency concern about inadequate controls to prevent labeling and packaging mixups prompted a national repacker to recall 174 drug products, swelling the total for the year. FDA is stressing the contamination risks of non-sterile products and is working with industry to upgrade microbial testing practices. [A 12-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 2006 is included.]
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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.’
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
