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British authorities have cited a U.S. drugmaker and an Indian drugmaker in recent weeks over multiple critical GMP violations at their facilities. Read More
The FDA has continued to hammer manufacturers with Form 483 citations, as evidenced by three in recent months tackling everything from sterility issues and data integrity to lax recordkeeping. Read More
The FDA has cited five U.S.-based drug compounders in as many weeks, with most of the complaints focusing on sterility issues, although questions of adulteration and issuing unapproved drugs also surfaced. Read More
To drive the manufacturing of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, to harmonize EU regulations and to exercise flexibility. Read More
The FDA has stepped up its enforcement efforts in Taiwan and mainland China in the past month, issuing warnings to two Taiwanese drugmakers and two Chinese companies. Read More
The European Medicines Agency is recommending that drugmakers update their risk management plans when switching to a new manufacturing process for products with centralized marketing authorization. Read More
The time and effort to collect quality metrics dictated in an FDA draft guidance are about three times higher than the agency’s original estimates. Read More
The federal appellate court has ruled that the Medicines Company’s use of third-party suppliers to manufacture its blood thinner Angiomax does not invalidate the drug’s patents, reversing an earlier panel decision. Read More
The Office of Generic Drugs has taken action on more than 90 percent of its backlog of ANDAs and prior approval supplements, more than 15 months ahead of schedule, CDER Director Janet Woodcock announced Monday. Read More
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More
The FDA has faulted two compounders for neglecting to apply quality controls to the production of their sterile drugs, pummeling one of the compounders with 13 citations. Read More