The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The drug regulator emphasised the importance of regulated distribution under the National TB Elimination Programme to ensure proper usage and monitoring.

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces FDA Award of Filing Fee Waiver for Upcoming NRX-100 (preservative free ketamine) New Drug Application to Treat Patients with Suicidal Depression ...

Select emergency preparation supplies will be tax-free in Texas this weekend. See which items do and do not qualify.

In addition to COPP, the DRAP Clearance Gateway has also begun offering electronic Free Sale Certificate, Good Manufacturing Practice (GMP) Certificate, and the No Objection Certificate (NOC) for ...

Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris International’s Zyn to help adult smokers cut back or quit cigarettes.

WASHINGTON (AP) — Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris International’s Zyn to help adult smokers cut back or ...

WASHINGTON (AP) — Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris International’s Zyn to help adult smokers cut back or ...