Regulatory and Washington

The Food and Drug Administration today released two guidance documents to assist drug companies that are developing the next generation of therapies and treatments.

President Trump today signed legislation prohibiting "gag clauses" at a ceremony at the White House, which was attended by executives from the National Association of Chain Drug Stores and the National Community Pharmacists Association.

FDA commissioner Scott Gottlieb said the agency is concerned with companies making claims about the plant’s ability to treat opioid withdrawal and addiction, as well as other serious medical conditions.

Colorado Gov. John Hickenlooper's signing of HB 1307, which prohibits the sale of OTC products with dextromethorphan to minors, has earned praise from the Consumer Health Products Association.

The FDA has issued a new draft guidance to promote more widespread development, access, and adoption of medication-assisted treatment products for opioid use disorder.

In an effort to address the opioid epidemic, the Food and Drug Administration is urging the development of opioid analgesic products that are harder to manipulate and abuse.

The National Association of Chain Drug Stores has submitted comments to Health and Human Services secretary Alex Azar in response to the agency’s request for information on drug pricing public policy issues.

H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, was passed by voice vote and includes provisions that would modernize the monograph pathway, which hasn’t had a significant update since its implementation in 1972.