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About 128 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, 3 weeks 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 Letter1 month ago FDA Strategies Designed to Speed Generic Drug Approvals  PharmTech.com1 month ago FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA  JD Supra2 months ago Implementing The Generic Drug User Fee Act: Struggles And Successes  AAPS Pharmceutica2 months ago

US FDA posts draft guidance on correspondence related to GDUFA Amendments

Outlines communication process between industry and agency US FDA published a notice in the Federal Register announcing the availability of a new draft guidance for industry, titled Controlled Correspondence Related to Generic Drug Development. ...
 Express Pharma1 month ago FDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers  JD Supra1 month ago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 News4 weeks ago FDA Generic Drug Facility Fees Due October 1, 2014  Tamar Securities1 month ago

Statement from Ralph G. Neas, President and CEO, GPhA, Regarding the FDA's Public Hearing on GDUFA

) - "Today, more than 50 individuals representing the generic drug industry and more than 20 Generic Pharmaceutical Association (GPhA) member companies stand together to call attention to areas where the Generic Drug User Fee Act (GDUFA) process and ...
 FirstWord Pharma1 month ago GPhA President and CEO Makes Statement Regarding the FDA's Public Hearing on GDUFA  Pharmacy Times1 month ago

EFCG calls for stricter rules on API and excipients made outside the EU

of all APIs sold in the European Union (EU) now come from non-EU sites and the current Falsified Medicines Directive (FMD) 2011/62/EU does not ensure that the APIs used in the EU comply with European GMP wherever they are made, said European Fine ...
 Manufacturing Chemist1 week ago

FDA/CMS Summit for Biopharmaceutical Executives Explores Innovation After Health Reform December 11-12, 2014, Washington, DC at the Fairmont

WASHINGTON, DC -- (Marketwired) -- 10/09/14 -- The health insurance expansion under the Affordable Care Act is in full swing -- a late enrollment surge helped the Obama Administration meet its goal of enrolling 7 million patients into the health ...
 Reliance Trust2 weeks ago
Glass On Web

Is delamination clouding the bigger picture in pharmaceutical glass containers

The current focus on delamination could be clouding the bigger pharmaceutical glass packaging picture and narrowing the options for potentially more cost-effective solutions, according to a leading glass analyst. Daniel Capon of independent ...
 Glass On Web2 weeks ago


Pharmaceutical export from India continues to be in trouble with the growing global competition and recurrent regulatory actions against some of the top Indian companies. India's total pharmaceutical exports registered slowest growth rate of just 2 ...
 PharmaBiz1 month ago

Outsourcing Perspectives from Catalent Pharma Solutions

Participants: Richard J. Holl, Ph.D., Director, Pharmaceutical Science Todd Stutzman, RPh, Director, Pharmaceutics Aileen Ruff, Strategic Director, Advanced Delivery Technologie Min Park, Group Product Manager, Advanced Delivery ...
 PharmTech.com1 month ago
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