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 agency said sponsors should take any necessary additional steps ahead of pediatric studies, depending on nonclinical pharmacology and toxicology findings observed in adults. Read More
Rather than replacing relationships between the FDA’s product centers and patient organizations, the committee aims to expand those connections. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use had a light meeting load this month, recommending approval for a single generic medicine and expansions of indications for six other drugs. Read More
A new Cancer Moonshot collaboration of NIH with 11 biopharmaceutical companies will undertake to identify and validate biomarkers to advance immunotherapies as its first order of business, the agency announced. Read More
The FDA will agree to meet to discuss the ANDA deficiencies cited in a complete response letter to a sponsor only if the sponsor lists the questions it wants to raise and the people who will participate in the meeting and includes other items spelled out by the agency in draft guidance, the FDA said. Read More
The FDA said that if an applicant requests a teleconference, the FDA will conduct the teleconference and decide 90 percent of the requests within 30 days. Read More