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About 97 results for "gdufa"

FDAnews Announces — Impact of GDUFA Performance Metrics on A...

For generic drugmakers, Oct. 1 is crunch time, the date after which all ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments (GDUFA) of 2012. Joan Janulis, a ... PRWeb, 1 month ago

GPhA calls for feedback and dialogue on US generic legislation

The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User Fee Act (GDUFA) process and implementation can be strengthened. In a statement yesterdayit praised generics for providing life-saving drugs for ...
 Pharma Letter2 months ago Statement from Ralph G. Neas, President and CEO, GPhA, Regarding the FDA's Public Hearing on GDUFA  FirstWord Pharma2 months ago GPhA President and CEO Makes Statement Regarding the FDA's Public Hearing on GDUFA  Pharmacy Times2 months ago New Era for Generic Drugs  PharmTech.com2 weeks ago

Generics Makers Concerned About FDA's Inactive Ingredient Database, Other GDUFA Issues

The FDA's database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, according to generics makers who laid out a variety of other shortfalls they see in the agency's generic drug approval process. The ...
 FDA News2 months 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 days 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.com5 days ago Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications  National Law Review6 days ago Proposed Criteria for "First Generic" Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User...  Pharmacy Choice6 days ago FDA Finds Two Concerta Generics No Longer Equivalent to Brand  FDA News1 week 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 Consumer5 days 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 Manufacturer6 days ago
Business Today India

Patent Litigation and Generic Drug Companies: How to Avoid Becoming an Exceptional Case

2013 brought generic drug companies increased financial and legal hurdles when it came to marketing their products in the U.S. First, substantial new GDUFA user fees got levied on generics for access to the FDA. Then, the Supreme Court returned its ...
 JD Supra1 week ago Indian drug firms see fall in US sales on FDA approval delays  Indian Mirror1 week ago US sales of Indian drug firms hit by delay in FDA approvals  Business Today India1 week ago
University of Bath

New research venture aims to lower cost of medicines

Bath is the first institution outside the United States to receive funding from the US Food & Drugs Administration (FDA), for amajor new research collaboration that will strive to open up the pharmaceutical drugs market and enable the design of ...
 University of Bath2 weeks ago

Approval delays to hurt Indian pharma cos' US sales

Indian drugmakers expect a slowdown in new generic drug approvals by the US Food and Drug Administration (FDA) to weigh on sales in their largest market for at least two more quarters, due to an ongoing overhaul of the review process. India's $15 billion pharmaceutical industry, which has been hit by a spate of regulatory sanctions in the past year due to concerns about production processes, supplies about 40 per cent of generic and over-the-counter drugs to the United States. The FDA ...
 Rediff.com1 week ago Indian Drugmakers Suffer US Regulatory Pain  Businessworld India1 week ago Dugmakers see US sales hit by approval delays  Reuters India1 week ago Indian drugmakers see U.S. sales hit by delay in new approvals  Reuters1 week ago
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