Search results for " drug"

Article Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…

Article Quality Systems Key to Lifecycle Drug Management
Pfizer is involved with some 24,000 postapproval changes a year for its 30,000 products, noted vice-president Roger Nosal at the April 2015 CMC Workshop sponsored by the Drug Information Association (…

Article Drug Discovery and Development in India
…f the country as a favorite destination for “chemistry” outsourcing followed by “collaborative drug discovery as contract agencies where in-house strengths in chemistry of local companies was augment…

Article Advances in Linker Technology: Improving the Safety and Efficacy of Antibody Drug Conjugates
With the approval of several antibody drug conjugates (ADCs) providing targeted delivery of cytotoxic APIs to specific sites of action, generally cancer cells at this point, their potential has been c…

Article New Era for Generic Drugs
Generic drugs now account for more than 85% of US prescription drug use, and the development of biosimilars promises to extend this trend to large molecules. Such transformation was unanticipated back…

Article FDA Seeks Metrics to Define Drug Quality
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern about drug quality and safety. Despite a decade of encouragement and guidance from FDA, manuf…

Article Manufacturers Struggle with Breakthrough Drug Development
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs” that offer exceptional promise in treating patients with serious medical needs. Such designa…

Article Breakthrough Drugs Raise Development and Production Challenges
Jul 01, 2015 By Jill Wechsler BioPharm International Volume 28, Issue 7, pg 8–9 The FDA program to expedite the development and approval of innovative drugs for serious and life-threat…

Article Global Expansion Shapes Drug Oversight
Few FDA officials discuss pharmaceutical regulation these days without reference to how the international reach of the biopharmaceutical industry has altered drug research, production, and regulation.…

Article Practical considerations for demonstrating drug substance uniformity
By Sushil Abraham, Eric Rydholm, and Phil Wagner ABSTRACT Drug-substance uniformity is an important consideration for the final step in the manufacture of drug substance/active pharmaceutical i…

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