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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for post-partum depression

The U.S. Food and Drug Administration approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

Influenza activity down slightly but remains high, CDC says

Reports of influenza cases inched downward during the week ending March 9, but they remain relatively high due in part to the spread of the H3N2 virus, the Centers for Disease Control and Prevention reported.

21st Century Cures Act: Interoperability, information blocking and the ONC Health IT Certification Program

While today's technology offers us a world of information that previous generations never even dreamed of being so accessible, important medical and health records remain time-consuming and difficult to obtain.

Natural Cycles contraception app gets final FDA clearance

This month the U.S. Food and Drug Administration took the final steps in clearing the first family-planning app approved for use in the U.S.

FDA regulations easier for devices than drugs

The U.S. Food and Drug Administration is the agency that ultimately decides upon the safety of medical applications, both pharmaceuticals and devices, and approves their use by providers to the public.

Administration proposes Medicare patients get coverage for innovative devices

The current administration’s proposed budget for 2020 includes allowing Medicare patients to benefit from more and longer access to “breakthrough” medical devices, and the industry could not be happier.

Feedback flowing in to FDA following draft policy document publication

Feedback is continuing to flow in the FDA following the publication of a draft policy document on the future of combination products.

U.S. FOOD AND DRUG ADMINISTRATION: On steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

Seminar scheduled for learning how to handle FDA recalls

No company wants its product recalled by the U.S. Food and Drug Administration, but it can happen despite the most careful product planning.

Medical device makers likely to benefit from ‘similar product’ expedited approval process in 2019

Keeping pace with technology that seems to develop at the speed of light and getting medical treatments to the people who most need them as quickly as possible while still maintaining top standards and keeping patients safe is tricky for the U.S. Food and Drug Administration, but that is its job.

FDA seeks to reform clinical trials

SILVER SPRING, Md. -- The Food and Drug Administration (FDA) wants to overhaul the current clinical trial process by giving patients, doctors and researchers clearer access to clinical trial information, according to a new FDA statement released by former FDA Commissioner Dr. Scott Gottleib, current FDA director of the Center for Devices and Radiological Health, Dr. Jeff Shuren, and current chief of staff to the FDA commissioner, Lauren Silvis.

U.S. FOOD AND DRUG ADMINISTRATION: Efforts to promote and foster blood pathogen reduction technologies

Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologies

U.S. FOOD AND DRUG ADMINISTRATION: New steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

U.S. FOOD AND DRUG ADMINISTRATION: Actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

FDA Reporter