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Generic drug applicants need to get their bioanalytics right when demonstrating bioequivalence to avoid costly delays or outright rejection by the FDA, an agency official warns. Read More
Members of the Senate Special Committee on Aging took Valeant Pharmaceuticals’ International officials to task over what they called the company’s practice of buying drugs with no generic competition and “jacking up” the prices. Read More
The House Appropriations Committee passed a fiscal 2017 agricultural appropriations bill in April that proposes a slight funding increase for the FDA, but still remains well below the agency’s funding request. Read More
The Office of Generic Drugs had a banner year in 2015, seeing more than 700 full and tentative approvals, the agency announced in April in its first-ever report on generics. Read More
The Kentucky state Senate has passed a bill in a 36 to 1 vote that would permit interchangeable biosimilar substitution. The FDA has not yet approved an interchangeable biosimilar. Read More
A three-judge panel for the U.S. Court of Appeals for the Federal Circuit has upheld two Depomed patents, enabling it to resume its lawsuit against Purdue Pharma. Read More
The FTC is arguing that a district court erred in failing to apply the Supreme Court ruling in FTC v. Actavis in a pay-for-delay case involving GlaxoSmithKline’s Wellbutrin XL antidepressant. Read More
As it bolsters efforts to tackle the growing opioid epidemic, the FDA last month outlined what tests sponsors of abuse-deterrent generic opioids should submit. Read More
A first cycle approval of a generic drug would ensure quick access in the market and eliminate the need for additional communications with the FDA. However, this may not always be possible, as GDUFA I does not provide for adequate communication between industry and the agency during the presubmission and ANDA review stages, Aloka Srinivasan, a principal consultant at PAREXEL International said in a recent FDAnews webinar. Read More
Participation in biosimilar development program activities with the FDA has seen a steady uptick over the past three fiscal years — from 33 in fiscal 2013, to 57 last year — according to an analysis by independent consulting firm Eastern Research Group. Read More