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About 201 results for "gdufa"

PCI Synthesis Predicts Key Trends Affecting the Generic Drugs ...

From the Wires Company Sees Faster FDA Approvals, Higher Fees Due to GDUFA and Robust Demand for CROs and CMOs Dec. 14, 2015 09:14 AM NEWBURYPORT, MA -- (Marketwired) -- 12/14/15 -- PCI Synthesis, Inc. ( ), a ... Sys-Con India, 2 months ago

1 images for "gdufa"

Contract Pharma, 2 weeks ago

GPhA responds to Senate HELP committee's GDUFA hearing

The Generic Pharmaceutical Association (GPhA) has applauded progress at the federal level on issues affecting it, including a hearing of the Senate Committee on Health, Education, Labor and Pensions (HELP). The Generic Pharmaceutical Association ...
 Pharmacist.com1 week ago

ChemWerth Hits Milestone with 50th DMF Available For Reference, Commits to Strong Pipeline of Future APIs

ChemWerth, Inc., is pleased to announce that since the inception of Generic Drug User Fee Amendments (GDUFA) in 2012, the company has filed its 50th Drug Master File that the FDA has deemed as Available for Reference. The company continues to rank ...
 Pharmacy Choice1 month ago GDUFA regulatory priorities for 2016 include complex drugs  GaBi Online2 months ago

Regulatory Resolutions

As is tradition, the FDA's Center for Drug Evaluation and Research (CDER) sends their publicity staff to corner the director to discuss major events from the year past and goals for the New Year. Dr. Janet Woodcock recently posted her thoughts and ...
 Pharmaceutical Manufacturing Magazine2 days ago
Processing Magazine

Pharma manufacturers with no US facilities may be left behind

U.S. pharmaceutical manufacturers are showing increased confidence in renewed growth and are returning some lower cost manufacturing work that was previously outsourced overseas, according to a new report from CPhI, part of UBM EMEA's Pharma ...
 Processing Magazine2 days ago Increased confidence of growth in US market, finds CPhI report  Manufacturing Chemist4 days ago

Cambrex Sell-Off A Golden Opportunity

Cambrex (NYSE: CBM ) is a generics and biosimilar manufacturer that provides small molecule pharmaceutical ingredients and finished dose products for the innovator and generic pharmaceutical markets. Shares have sold off in the last three months ...
 Seeking Alpha4 days ago
European Pharmaceutical Review

CPhI Worldwide launches pharma insights 2016 USA report at InformEx 2016

CPhI report warns international manufacturers about the need to invest in domestic US sites and indicates that US CDMOs are well placed to keep biosimilars development work into commercialisation Amsterdam, 4 th February 2016: CPhI , part of UBM ...
 FiercePharmaManufacturing5 days ago CPhI announces findings from its review of the US pharma manufacturing market  European Pharmaceutical Review1 week ago

FDA Publishes Blog On Modernizing Generic Drug Review Processes

In response to the House Committee on Oversight and Government Reform's Feb. 4, 2016 hearing to address the rise in prescription drug prices, Steven Ostroff, acting commissioner of food and drugs at FDA, published a blog for the agency citing the ...
 PharmTech.com5 days ago Building a modern generic drug review process  Pharmacist.com1 week ago

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress's complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing .
 Lexology1 week ago

Senate Scrutinizes Generic Drug Approval Backlog

A US Senate committee recently held a hearing to investigate the culprits behind the growing backlog of generic drug applications at the FDA. The Generic Drug User Fee Amendments (GDUFA), which took effect in 2012, were designed to expedite the ...
 Pharmacy Times1 week ago
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