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Drugmakers operating in the EU must submit additional information to the European Medicines Agency on their authorized products starting immediately, and update previously submitted information by year’s end. Read More
Drugmakers hoping to market generic and biosimilar products quickly in Brazil should pair up with the branded firms to facilitate the application process, according to an updated rule that aims to speed generic approvals. Read More
Drugmakers submitting regulatory filings in the U.S., Europe and Japan generally may use pharmacopeia texts on dosage units interchangeably in the three regions, according to a final FDA guidance that adopts guidelines from the International Conference on Harmonization. Read More
The European Medicines Agency is streamlining the declarations that Qualified Persons must file to assure the agency that makers of active substances are compliant with good manufacturing practices. Read More
For the third year in a row, pharmaceutical companies are filing more proposals with the European Medicines Agency’s pediatric committee seeking approval for the development of drugs for children. Read More
The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based. Read More
Generic drug giant Teva received FDA clearance May 30 to market exclusive versions of Pfizer’s blockbuster arthritis pain drug Celebrex (celecoxib) in the 100 mg, 200 mg and 400 mg capsule forms. Read More
Eli Lilly said it will begin sharing clinical trial data used in support of regulatory filings in the U.S. and Europe with qualified researchers, becoming the latest drugmaker to join the growing clinical trial data transparency movement. Read More
House lawmakers advanced an FDA funding package that directs the agency to address a multitude of controversial issues, including justifying the costs to generic drugmakers of the agency’s proposed labeling overhaul. Read More