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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The FDA released a draft guidance Thursday recommending ways to demonstrate if new drugs or drug uses are effective for certain low-prevalence rare diseases caused by single enzyme defects.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
The bill would bar insurers or pharmacy benefit managers from restricting a pharmacy’s ability to provide drug price information to a plan enrollee. Read More