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About 73 results for "gdufa"

Drug firms face ANDA blues
Financial Express

Drug firms face ANDA blues

Summary The delay in approval of generic drug applications, which has been slowly declining annually, witnessed its lowest run-rate in the first half of… The delay in approval of generic drug applications, which has been slowly declining ... Financial Express, 6 days ago

FDA's Office of Pharmaceutical Quality Ramps Up Process to Accelerate ANDA Reviews

In a preview of how the FDA's Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues ...
 FDA News1 week ago

Biotech and Generic Drugs: 2015 Trends and Predictions

Editor's Note: Ed Price, President of PCI Synthesis, Inc. ( ), a manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products based within the Boston area ...
 PharmaceuticalProcessing1 week ago PCI Synthesis Announces 2015 Trends And Predictions  BioSpace1 week ago PCI Announces 2015 Trends and Predictions  SearchBug1 week ago

Solutions to Global Pharmaceutical Supply Chain Challenges

New white paper released by Pharma Packaging Solutions. Pharma Packaging Solutions announced the release of a new white paper which can be downloaded here: ...
 PRWeb1 week ago


NEW DELHI: In November, manufacturing activity in India rose to a 21-month high, though that didn't lead to additional hiring, showed the HSBC Purchasing Managers Index (PMI), released on Monday. The data also pointed to an uptick in price ...
 IPA Newspack.com2 weeks ago

Generic Drugs Face New Regulatory Future

The 30th anniversary of the Hatch-Waxman Act in September generated widespread recognition of how the legislation created today's vibrant generic-drug industry. Generic drugs now account for more than 85% of US prescription drug use, and the ...
 PharmTech.com2 weeks ago New Era for Generic Drugs  PharmTech.com1 month ago
Seeking Alpha

Flamel Technologies: A Turnaround Story With Lots Of Upside

Summary Flamel Technologies is a drug delivery company with proprietary technologies for controlled release dosage forms. Near term path to profitability (4Q14) driven by FDA approval of currently unapproved but marketed drugs (UMDs) with ...
 Seeking Alpha4 weeks ago

FDA Requests Comments on Generic Drug Submission Criteria

FDA is requesting comment on proposed criteria for first generic abbreviated new drug application (ANDA) submissions. The agency has established criteria for the review prioritization pursuant to the Generic Drug User Fee Amendments of 2012. FDA ...
 PharmTech.com1 month ago Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications  National Law Review1 month ago Proposed Criteria for "First Generic" Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User...  Pharmacy Choice1 month ago FDA Finds Two Concerta Generics No Longer Equivalent to Brand  FDA News1 month ago
Food Consumer

FDA Updates for Health Professionals - 11-19-14

As part of our ongoing efforts to keep you informed about FDA,theOffice of Health and Constituent Affairswants to make you aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, ...
 Food Consumer1 month ago

Re-designed drugs could be made cheaper

A new research collaboration is hoping to enable the design of better and cheaper medicines, according to scientists involved in the project at the University of Bath (UK). The research consortium, Research in Medicines Design (ReMedDes) will ...
 European Pharmaceutical Manufacturer1 month ago
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