We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Starting statin therapy earlier in people with lower risks of cardiovascular disease (CVD) could save thousands of lives and billions of dollars annually, according to guidance issued Friday from the UK’s healthcare costs regulator. Read More
Manufacturers reporting adverse events suspected to be caused by vaccines should submit their individual case safety reports via the agency’s electronic submissions gateway in XML format, says a new draft guidance that completely overhauls a 1998 predecessor. Read More
The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
The FDA this week approved the first human recombinant C1-esterase inhibitor product for adolescents and adults with acute attacks of a rare condition called hereditary angioedema (HAE). Read More
Starting next year, drugmakers in Canada will need to submit for premarket review information on proposed drug names, labels and packages under amended regulations that aim to ensure drug labeling is clear and easy to understand and a drug can’t be confused with another product. Read More
SAN DIEGO — The FDA is racing to beat a fall deadline to release a string of new guidances for generics makers that it hopes will head off a potential torrent of rejected submissions. Read More
French drugmaker Servier and five generics firms are facing roughly $580 million in fines from European antitrust regulators over an alleged pay-for-delay scheme. Read More
Drugmakers hoping to market generic and biosimilar products quickly in Brazil should pair up with the corresponding branded firms to facilitate the application process, says an updated rule that aims to speed generic approvals. Read More
The FDA has laid out new goals for speeding up its handling of regulatory submissions from generics makers that eventually call for 90 percent of some prior approval supplements to be acted on within six months and ANDA amendments to be acted on within 10 months. Read More
Massachusetts has become the eighth state to pass a law enabling pharmacists to substitute a biosimilar for a branded biological product, earning praise from industry groups that believe such state laws are vital to biosimilar adoption. Read More