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July 23, 2009
The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances.
April 23, 2009
The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).
The US Food and Drug Administration issued a draft guidance for industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDAs).
March 05, 2009
In a press release dated Feb. 25, 2009, the US Food and Drug Administration charged that Ranbaxy Laboratories's (Gurgaon, Haryana, India) Paonta Sahib facility falsified data and test results in approved and pending drug applications.
November 20, 2008
Although the number of annual new-drug approvals in the United States has steadily declined during the past ten years, pharmaceutical companies still prefer to introduce new products in the US first, according to a report published by the Tufts Center for the Study of Drug Development.
August 27, 2008
FDA has finalized a regulation regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval applicatin (PMA).
June 19, 2008
With most deadlines missed for reviewing each abbreviated new drug application (ANDA) it receives, the US Food and Drug Administration is likely to take advice from the US Department of Health and Human Services (HHS) on how to speed up its process.
Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.
January 17, 2008
The US Food and Drug Administration approved 69 new drug applications last year, the second lowest number of approvals in the past decade, according to the Jan. 15 edition of Drug Industry Daily.
January 10, 2008
The US Food and Drug Administration released a draft plan for modifying its information technology infrastructure. The plan follows the renewal of the Prescription Drug User Fee Act (PDUFA IV).