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The FDA has released a revised guidance document spelling out when new drug applications (NDAs) for the marketing of botanical drug products are required and when such a product can be marketed under an OTC drug monograph.
GlaxoSmithKline (GSK) filed a citizen petition with the FDA that is delaying final approval of a generic version of the company’s profitable allergy nasal spray drug Flonase, generic drug sources said.
Sen. Judd Gregg (R-N.H.) last week introduced legislation to legalize drug imports from Canada and the European Union that includes provisions to establish federal licensing requirements and penalties for internet pharmacies.
The FDA’s decision last week to cancel its June 11 public meeting to address possible Part 11 rule revisions created even more confusion in the industry, which has been struggling to get a clear fix on the agency’s direction regarding electronic signatures and electronic recordkeeping.
The FDA last week pushed back the timeline for implementing the structured product labeling (SPL) file format requirement, effectively extending the deadline for companies to begin using the new standard when submitting drug-labeling data.
The FDA has issued a new International Conference on Harmonisation guidance containing recommendations for evaluating the stability data needed to propose a retest period for a drug substance and a shelf life for a drug product.
An internal review of FDA employee records to determine possible conflicts of interest has not identified any additional approved outside activities of concern, acting FDA Commissioner Lester Crawford announced.
The FDA has signed a contract with an independent consultant to examine why first-cycle drug reviews fail, the head of the Center for Drug Evaluation and Research (CDER) said last week at the Biotechnology Industry Organization’s annual convention in San Francisco.
The FDA will not release its much-anticipated guidance detailing scientific issues on follow-on biologics this summer as originally announced, saying it needs more time to put together a list of approved products.
On June 8 the FDA released a warning letter to biotechnology firm Celsion on May 7 that details violations discovered during the Phase I and Phase II trials of its Prolieve Thermodilatation system.