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European regulators have selected nine applicants out of 29 manufacturers who submitted proposals to participate in the EMA’s adaptive pathway pilot project, which aims to speed drug approvals by authorizing products in stages for targeted populations. Read More
The FDA has unveiled the 14 members of its reconstituted Pharmacy Compounding Advisory Committee, a group that will play an influential role in deciding which products will be prohibited from compounding under a 2013 law. Read More
Janssen, GlaxoSmithKline and NewLink Genetics will be safe under a law that protects companies producing treatments to combat health emergencies. Read More
The U.S. Supreme Court declined to hear an appeal of a ruling that had struck down an Arizona law banning the use of the abortion drug RU-486 alongside misoprostol, a decision that effectively confirms earlier court positions upholding the FDA’s off-label drug use policy. Read More
The Senate late Saturday approved a spending bill that gives the FDA nearly $1.7 billion in drug and biologic regulatory funding, a $48 million increase over current levels. Read More
The drug pricing authority in India added 52 more drugs under price control, including products used to treat pain, cancer, skin disorders and infections, as part of a program to provide life-saving and essential medicine's to the country’s population. Read More
India’s health ministry is proposing to spend more than $280 million to strengthen the country’s national and state drug regulatory systems, with the aim of speeding approval decisions and testing of products. Read More
Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. Read More