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About 90 results for "gdufa"

US FDA issues norms on ANDA submissions prior approval supplem...

US FDA has issued a set of guidelines to assist pharma companies preparing to submit prior approval supplements (PASs). These are also amendments to PASs for abbreviated new drug applications (ANDAs). The guidance elucidates how the Generic Drug ... PharmaBiz, 3 weeks ago

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Industry Supports GDUFA II Proposals, Advancing Reauthorization of Fee Program

Oct. 28, 2016 Industry groups have backed the FDA's commitment goals for GDUFA II, bringing the user fee program for generics makers closer to reauthorization after a public meeting. Industry representatives from GPhA, the Bulk Pharmaceuticals ...
 FDA News1 month ago Industry Groups Applaud GDUFA Agreement  PharmTech.com1 month ago FDA Releases Guidance on GDUFA Self-Identification  BioPharm International1 month ago FDA to set up abbreviated pathway for complex products  GaBi Online1 month ago
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Final GDUFA Guidance Clarifies Penalties for Unpaid User Fees

Nov. 30, 2016 Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017. Sponsors that are ...
 FDA News2 days ago

GDUFA II Fee Structure Modifies Revenue Model to Predictable Annual Dues

Oct. 25, 2016 The FDA is proposing annual dues for sponsors of one or more approved ANDAs to guarantee a more predictable stream of funding that will raise revenues for the agency's generics program starting in fiscal 2018. In a summary of the ...
 FDA News1 month ago

GDUFA II Goal: Evaluate 90 Percent of Priority Submissions in Eight Months

Oct. 24, 2016 The FDA intends to review 90 percent of priority review ANDAs deemed complete within eight months, according to the agency's GDUFA II commitment letter. The full commitment letter further explains the performance goals the FDA ...
 FDA News1 month ago

David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, Remarks on GDUFA II

You currently are not registered for any FirstWord Pharma services. Register to FirstWord Pharma for free access to 10 articles every 30 days: You can also: Wait 11 days for your content allowance to be renewed. Sign up for a free trial to ...
 FirstWord Pharma1 month ago
Contract Pharma

GDUFA II Update

It's been about six months since I last checked in with news from the Pharma & Biopharma Outsourcing Association (PBOA). At the time, the PBOA was immersed in negotiations with FDA and other industry groups for the reauthorization of the Generic ...
 Contract Pharma1 month ago

FDA reports record number of generics approvals

The OGD updated its Activities Report for the FY2016 on 10 November 2016, providing important information on its Generic Drug Program. The report shows that the Office approved 835 generic drugs for FY2016 the largest number of approvals for at ...
 GaBi Online14 hours ago
ADVFN India

TELIGENT, INC. : Announces FDA Approval Of Clobetasol Propionate Lotion 0.05%

BUENA, N.J., Nov. 30, 2016 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S.
 4 Traders2 days ago Teligent receives US FDA approval for clobetasol propionate lotion  PharmaBiz15 hours ago Teligent, Inc. Announces FDA Approval Of Clobetasol Propionate Lotion 0.05%  Pharmacy Choice2 days ago Teligent Announces FDA Approval Of Clobetasol Propionate Lotion 0.05%  BioSpace2 days ago
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Edited Transcript of ACET earnings conference call or presentation 3-Nov-16 1:00pm GMT

Q1 2017 Aceto Corp Earnings Call Lake Success Nov 28, 2016 (Thomson StreetEvents) -- Edited Transcript of Aceto Corp earnings conference call or presentation Thursday, November 3, 2016 at 1:00:00pm GMT TEXT version of Transcript ...
 Yahoo! Finance4 days ago Edited Transcript of VEC.L earnings conference call or presentation 23-Nov-16 9:30am GMT  Yahoo! Finance1 week ago Vectura Group plc Interim Results  ADVFN UK1 week ago
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