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. ( www.pcisynthesis.com ), a ... Sys-Con India, 2 months ago
PCI SYNTHESIS : Predicts Key Trends Affecting the Generic Drugs Sector in 2016 - 4 Traders, 2 months ago
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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.com, 1 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 Choice, 1 month ago GDUFA regulatory priorities for 2016 include complex drugs GaBi Online, 2 months ago
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 Magazine, 2 days ago
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 Magazine, 2 days ago Increased confidence of growth in US market, finds CPhI report Manufacturing Chemist, 4 days ago
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 Alpha, 4 days ago
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 ...FiercePharmaManufacturing, 5 days ago CPhI announces findings from its review of the US pharma manufacturing market European Pharmaceutical Review, 1 week ago
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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.com, 5 days ago Building a modern generic drug review process Pharmacist.com, 1 week ago
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 .Lexology, 1 week ago
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 Times, 1 week ago
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