Dr. Reddy’s Petition Seeks Swift Review For Certain Secondary ANDA Filers
Dr. Reddy’s has come up with a new strategy for some secondary ANDA applicants to get their products on the market quicker.
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ANDA User Fee Negotiations: A Big-Firm Coalition Tackles The Big Backlog
FDA has long negotiated its brand user fee program with two distinct but closely aligned industry groups: the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization. Now the agency will be using those same discussion techniques as it develops the generic drug user fee program.
FDA Reverses Stance On Bioequivalence Standards For Mesalamine
FDA believes that comparative pharmacokinetic studies, instead of comparative clinical endpoint studies, are best for determining bioequivalence of extended- or delayed-release mesalamine products - a reversal of its previous position
Citizen Petitions Are Not Proper Way To Initiate FDA Enforcement Actions, Agency Says
FDA rejects a 2002 petition by Paddock Laboratories asking the agency to take action against manufacturers of ammonium lactate cream and lotion.