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 FDA released an updated version of its 2013 Manual of Policies and Procedures (MAPP) outlining CDER’s procedures for determining pharmacologic classes for use in prescribing information for drugs. Read More
AstraZeneca filed suit against generic manufacturer Accord Pharmaceuticals for alleged infringement upon four patents for AstraZeneca’s breast cancer drug Faslodex (fulvestrant). Read More
CDER Director Janet Woodcock Friday announced details of two new voluntary programs designed to support improvements in product and process quality and to enhance the agency’s use of quality metrics. Read More
The expert group called for more data, possible further trials and a clearer distinction between COPD and asthma before they could endorse the drug’s efficacy. Read More
The FDA released a draft guidance Thursday recommending ways to demonstrate if new drugs or drug uses are effective for certain low-prevalence rare diseases caused by single enzyme defects. Read More
An FDA advisory committee agreed Thursday that 60 Degrees Pharmaceuticals proved the safety and efficacy of its NDA for tafenoquine indicated for the prevention of malaria in adults. Read More
The FDA on Thursday issued final guidance closing a loophole under which drug sponsors could avoid their obligation to study drugs in pediatric indications. Read More