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 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The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable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
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee declared the chemotherapy drug docetaxel safe to use after it concluded that there is no evidence of changes in the known risk of intestinal inflammation after treatment. Read More
The European Medicines Agency recommended eight new drugs for approval, including two combination treatments for hepatitis C, two therapies for advanced cancers and one drug for relapsing multiple sclerosis. Read More
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More
The European Medicines Agency published a step-by-step guide for drugmakers to prepare for the implementation of the new EudraVigilance adverse event monitoring system, scheduled for Nov. 22. Read More
The European Medicines Agency says marketing authorization holders must be based in the European Economic Area post-Brexit — and UK-based companies will likely need to transfer marketing authorizations to new addressees. Read More