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Republican lawmakers Tuesday blasted CDER Director Janet Woodcock for the FDA’s consulting with trial attorneys and not brand or generic drugmakers when developing a controversial proposed overhaul of generic drug labeling rules. Read More
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. Read More
Drugmakers must now give Brazil’s ANVISA a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More
The European Medicines Agency has backed off of several controversial limitations that it was contemplating imposing on sponsors designing trials for treatments for chronic primary immune thrombocytopenia (ITP). Read More
The FDA has warned GlaxoSmithKline subsidiary SmithKline Beecham over its failure to adequately address contamination of drug ingredients manufactured at its Currabinny, Carrigaline, Cork, Ireland, plant. Read More
A federal court tentatively approved a $60 million payout by Hospira to end a class-action lawsuit that claimed the drugmaker misled investors about its quality problems. Read More
Novartis said Monday it has halted the Phase III trial of its chronic heart failure drug LCZ696 after being notified by a data monitoring committee that the drug met its composite primary endpoint of delayed cardiovascular death and reduced heart failure hospitalizations. Read More
Teva scored a legal victory Monday when the U.S. Supreme Court agreed to hear its appeal of a lower court ruling invalidating a patent for the drugmaker’s blockbuster multiple sclerosis drug Copaxone. Read More
The FDA has outlined the annual fees that large drug compounders that register as outsourcing facilities will have to pay the agency under new federal law. Read More