A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, the nation’s chief drug regulator said today.
The head of the U.S. Food and Drug Administration said she will visit India to talk with generic- drug makers and regulators about quality concerns and plans to expand overseas inspections to address the country’s growing role in producing medicines sold in the U.S.
Indian companies supplying a quarter of the medicines used in the U.S. must take responsibility for the quality-control necessary to export their products, the top U.S. drug regulator said as it ramps up inspections.
The top U.S. drug regulator asked Congress for more authority over pharmacies following the deadly meningitis outbreak, a request met with resistance by lawmakers who said existing oversight hasn’t been used to the fullest.
Makers of electronic cigarettes such as Lorillard Inc. and Altria Group Inc. will for the first time face regulatory oversight, including passing a review to stay on the market, under a U.S. plan that doesn’t ban TV ads or flavored versions of the new products.