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The FDA outlines drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance. Read More
HHS has published a subset of its semiannual rulemaking agenda for 2023, outlining those planned rules – including several from the FDA – that are likely to have a significant economic impact for some small entities.
ANDA applicants should submit a request for a PSG teleconference within 60 days after publication of a new or revised PSG so that the FDA can provide timely feedback, the agency said. Read More
TG Therapeutics would have to cut the price of its newly approved multiple sclerosis antibody Briumvi (ublituximab) by up to 84 percent to meet the same cost-effectiveness threshold as other monoclonal antibodies used to treat the disease, according to a report by the Institute for Clinical and Evidence Review (ICER). Read More
The FDA is considering asking Congress for enhanced authority over opioid approvals and marketing to ensure that new products offer “material safety advantages” over existing approved opioid analgesics. Read More
The FDA has released new details for companies preparing to submit an abbreviated new drug application (ANDA) on how to request meetings relating to a new or revised product-specific guidance (PSG) that may impact their application. Read More