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About 54 results for "gdufa"

Stephen Richardson Appointed As Chief Scientific Officer Of IGI Laboratories, Inc.

Stephen Richardson Appointed As Chief Scientific Officer Of IG...

BUENA, N.J. , Oct. 5, 2015 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey -based specialty generic pharmaceutical company, today announced that Stephen Richardson has been appointed Chief Scientific Officer (CSO) of IGI ... Marketplace, 3 days ago

Why Wall Street loves to hate Mylan's CEO

At 6 a.m. on thursday, July 23, Heather Bresch was running on the treadmill in her home gym when she found out that four men in Amsterdam had effectively seized control of half her company. In Bresch's wild world, this qualified as wonderful ...
 Fortune3 weeks ago

Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry

Image Source/ Controlled correspondence provides a crucial communication mechanism between FDA and the generic pharmaceutical industry. Such a mechanism allows the industry to seek for the agency's input prior to the submission of an abbreviated new ...
 PharmTech.com1 month ago

How faster FDA nods will help Indian generics makers

By Vikas Dandekar MUMBAI: A long spell of sluggish approvals for generic drugs in the US may be nearing an end with early signs of a rebound. A backlog of as many as 4,000 pending applications at the US Food and Drug Administration (USFDA), of which a fourth ...
 Economic Times1 month ago
Virtual Strategy Magazine

FDA Publishes FY 2016 Medical Device and Generic Drug User Fees

The U.S. FDA published medical device and generic drug user fee rates for FY 2016. Registrar Corp reports on the fees. Hampton, VA (PRWEB) August 05, 2015 In early August each year, the U.S. Food and Drug Administration (FDA) publishes various ...
 Virtual Strategy Magazine2 months ago Generic Drug User FeeAbbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active...  Pharmacy Choice2 months ago

FDA Issues Notice on Generic Drug User Fee-Abbreviated Application

Targeted News Service WASHINGTON, Aug. 2 The Department of Health & Human Services published the following notice in the Federal Register from the Food & Drug Administration: Generic Drug User Fee-Abbreviated New Drug Application, Prior ...
 Pharmacy Choice2 months ago
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