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A global regulatory group is following the EU’s lead in recommending that drugmakers use a risk-management approach to qualify and validate manufacturing processes. Read More
The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in a Wednesday citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
The Federal Trade Commission can pursue billions of dollars in repayments from Cephalon over alleged pay-for-delay tactics to stall the marketing of a generic version of Provigil, the brandmaker’s narcolepsy drug. Read More
Otsuka is again urging a federal judge in Maryland to prevent the FDA from granting any ANDA for generic versions of Abilify, after the agency indicated this week it had not yet decided whether the blockbuster antipsychotic drug’s exclusivity bars generic approvals. Read More
Brandmaker AbbVie and generics firm Teva are facing a second lawsuit over accusations they illegally delayed generic competition on the cholesterol medication Niaspan. Read More