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.
The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes immediately. Read More
Following further reports of drug tampering, Australia’s Therapeutic Goods Administration expanded an ongoing recall to include Arrow Pharmaceuticals and Novartis’ Sandoz. Read More
The White House could be pushing for lower prices by way of speeding drugs to market and promoting competition—even internationally—according to a draft executive order that could have the president’s signature soon Read More
The U.K. is planning to move Roche’s Kadcyla (trastuzumab emtansine) into the NHS’s routine funding programs later this summer, following guidance from the National Institute for Health and Care Excellence and an agreement from Roche to lower the cost of the breast cancer treatment. Read More
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More
The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be imported into the U.S. Read More
The European Commission updated its 2011 action plan against antimicrobial resistance, pledging to boost research into the development of new treatments and alternatives — including support for small- and medium-sized companies — and develop guidelines for the prudent use of the drugs. Read More