STAT
DECEMBER 2, 2022
as a way to expand access for therapeutic purposes to potentially beneficial but highly regulated Schedule I substances like psilocybin and LSD, has the right underlying idea but provides a solution that is wrong. The Breakthrough Therapies Act , recently proposed by Senators Rand Paul (R-Ky.) and Cory Booker (D-N.J.)
PharmaTech
MAY 22, 2024
With a focus on cGMP compliance, the facility provides chemistry, microbiology, and regulatory consulting services, including testing for controlled substances. It ensures consistent quality across its network, prioritizing customer satisfaction and regulatory compliance throughout the drug development process.
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European Pharmaceutical Review
JUNE 26, 2023
Dr Tiffany Farchione, Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research stated the regulatory body “hopes to outline the challenges inherent in designing psychedelic drug development programmes” and provide potential solutions.
European Pharmaceutical Review
DECEMBER 21, 2022
Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. Fast track designation.
Pharmaceutical Technology
DECEMBER 5, 2022
However, at the federal level, cannabinoids remain illegal under the Controlled Substances Act. These countries utilize full legal oversight on cannabinoid medical use, cultivation and trade, which has established a robust regulated market, helping the region to deal with future developments.
FDA Law Blog: Biosimilars
NOVEMBER 6, 2023
The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. is the largest dedicated food and drug law firm in the country.
Pharmaceutical Technology
SEPTEMBER 23, 2022
The company focuses on small molecule, oral liquid, and solid dose products, providing formula development, method development, cleaning verification methods, tech transfer, pilot studies, commercial scale-up, and packaging. This will help determine if there are any special handling requirements.
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