The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos...more
The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more
The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells
On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more
6/8/2018
/ Clinical Trials ,
FDA Approval ,
Institutional Review Board (IRB) ,
Manufacturers ,
Medical Research ,
New Legislation ,
Patient Safety ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Right to Try ,
Trump Administration ,
Written Consent
On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more
6/8/2018
/ Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Drug Approvals ,
Drug Design ,
Drug Safety ,
Drug Testing ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Recruitment Incentives ,
Regulatory Reform ,
Trump Administration
The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more
On Nov.18, Congress enacted sweeping changes to the laws governing the safety of the drug supply. The Drug Quality and Security Act (the act) clarifies FDA's authority to regulate drug compounding. It also creates uniform...more