JuliaHub is doubling its investment in the pharmaceutical sector, leveraging JuliaHub’s new-and-improved CFR Part 11-compliant pharmaceutical platform. This latest release introduces advanced ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

The Food and Drug Administration announced it would decide by April 2024 whether chemical hair straightening products sold in the U.S. would be banned from using formaldehyde or ingredients that ...

Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind ... US dealing with treatment-resistant depression. Over 21 million Americans report depression-related issues.

Jan. 21 (UPI) --The Food and Drug Administration has approved the first-ever stand-alone nasal spray to treat drug-resistant depression. Johnson & Johnson's Spravato has been approved to treat a ...

Pape was associate chief counsel for foods at the FDA. Pines was associate commissioner for public affairs for the FDA. Zeller was director of the FDA Center for Tobacco Products. There has been ...

Jan 21 (Reuters) - Atara Biotherapeutics (ATRA.O), opens new tab said on Tuesday the U.S. health regulator had placed a clinical hold on its trials for cancer cell therapies, sending the drug ...

The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for three substances: ...

The Food and Drug Administration OK'd 10 Zyn flavors, including coffee, mint and menthol. It's the first time regulators have authorized sales of nicotine pouches, which are the fastest-growing ...

including deficiencies tied to 21 CFR Part 11, 6 which governs electronic records, systems and signatures of FDA-regulated entities (see our recent alert on the updated Part 11 FDA guidance).