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About 53 results for "gdufa"

BPTF Calls for Changes to GDUFA

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates, asked FDA at a June 15 public meeting to consider several changes to performance goals and the fee payment schedule prior to ..., 2 weeks ago

FDA, Generic Manufacturers Want Faster GDUFA Approvals

Generics industry groups told FDA officials during a public meeting Monday that review times and approvals of generic drugs have slipped significantly since implementation of the Generic Drug User Fee Act, and they called for major changes when ...
 FDA News2 weeks ago Generics Industry Calls for Changes to GDUFA  PharmExec.com2 weeks ago Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder...  Pharmacy Choice1 month ago FDA Seeks Information Collection on Generic Drug User Form  Pharmacy Choice1 month ago

US generic drugmakers note shortfalls in FDA implementation of GDUFA

In a statement by Ralph Neas, president and chief executive of the US trade group the Generic Pharmaceutical… In order to access this content you need to be logged into the site and have an active subscription or trial subscription. Please login ...
 Pharma Letter2 weeks ago Statement by Ralph G. Neas, President and CEO, GPhA on the June 15th FDA Public Meeting on GDUFA  FirstWord Pharma2 weeks ago

FDA to hold public meeting on GDUFA

Posted 08/05/2015 The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Generic Drug User Fee Act (GDUFA) performance goals and ways to improve procedures, ahead of negotiations to reauthorize the ...
 GaBi Online1 month ago HSCA Urges FDA to Address Growing Backlog of New Drug Applications  Healthcare Matters1 month ago

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Controlled...

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development Notice. Citation: "80 FR 38211" ...
 Pharmacy Choice2 days ago

Top Takeaways From BMO's Specialty Pharma Day

In a report published Wednesday, BMO Capital Markets analyst David Maris discussed key takeaways from a day of meetings with several specialty pharmaceutical companies. Below are some of the highlights of notable presentations. Allergan PLC ...
 Yahoo! Finance3 days ago

Health Care Law Update for June 22, 2015

Post-King v. Burwell Strategy is TBD : Health care stakeholders and policymakers alike, are anxiously awaiting a decision from the Supreme Court to what many health policy experts describe as one of the last serious challenges to the Affordable Care ...
 National Law Review1 week ago
Calcutta Telegraph

Drug firms bank on faster US approvals

Mumbai, June 21: Domestic pharmaceutical companies are pinning their hopes on faster clearances from the US Food and Drug Administration (USFDA) amid challenges such as compliance issues and customer consolidation. Experts, however, maintain that ...
 Calcutta Telegraph1 week ago
Pharmaceutical Online

Drug Shortages Highlight Quality Problems

By Trisha Gladd , Chief Editor, BioProcess Online Follow Me On Twitter @bioprocessol In an article written by Peter Loftus at the Wall Street Journal , a patient affected by the shortage of the cancer drug BCG was quoted as saying, This totally ...
 Pharmaceutical Online4 weeks ago

FDA Updates Refuse-to-Receive Rules for ANDA Submissions

The FDA has updated its guidance on refuse-to-receive criteria for ANDAs to include a reference to the Office of Pharmaceutical Quality, which didn't exist when the guidance was finalized. The guidance, which was introduced as a draft in ...
 FDA News1 month ago
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