On June 2, 2026 in The Wall Street Journal, Charles L. Hooper and David R. Henderson wrote “…Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives. Medicine is a matchmaking exercise in which potentially beneficial drugs […]
Today, the FDA published a draft guidance titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Guidance for Industry,” aimed at implementing streamlined approaches for nonclinical safety assessments of certain oncology pharmaceuticals. The draft guidance can be found here. The document provides some interesting background on the evolution of the Agency’s thinking […]
A Federal Register (FR) notice that appeared on today’s pre-publication page discusses a request for comments on a draft nondisclosure agreement (NDA) for federal employees. The notice (here) discusses the proposed NDA to affirm “[f]ederal employees’ acknowledgment of, and agreement to comply with, current legal obligations to safeguard non-public, confidential, or proprietary information, created or […]
The Federal Register (FR) notice (here) appearing on today’s pre-publication page describes the long and tedious process of finalizing one of the last remaining Drug Efficacy Study Implementation (DESI) notices, and ends with a final FDA decision that there is a lack of substantial evidence of efficacy for the use of certain estrogen-androgen fixed combination […]
Today, the FDA sent out a PDUFA Dear Colleague letter (here) asking firms to verify program fee assessment information that the Agency has relative to applications covered under PDUFA VII. The letter states that “[u]nder PDUFA VII, a program fee is assessed annually for certain prescription drug products identified in a human drug application approved as of […]
On April 29, 2026, the FDA published a notice in the Federal Register (FR) (posted on the FR prepublication page (here)) announcing the FDA’s intention to withdraw approval of the New Drug Application (NDA) for TAVNEOS (avacopan) capsule, 10 milligrams (mg), held by ChemoCentryx, Inc. and offer the applicant an Opportunity for a Hearing regarding the FDA’s […]
A few months before the end of 2025, the FDA requested that Glaxo Smith-Kline (GSK) revise its approved labeling by submitting a supplemental application to its Wellcovorin (leucovorin calcium) to include an indication for cerebral folate deficiency (CFD), a rare disorder. This came after Secretary Kennedy’s thus far unsuccessful hunt for the cause of autism. […]
Today, FDA approved Lilly’s GLP-1 oral tablet as the first approval of a new molecular entity (NME) through the CNPV program. The FDA says the drug Foundayo (orforglipron), “was approved 50 days after the NDA was filed and 294 days before the application’s PDUFA date of January 20, 2027”. According to the FDA (here), commissioner […]
Every 3 months, FDA updates its New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System listings (here) to include newly identified potential serious risks that FDA is investigating. The FDA wants to emphasize that “[T]he appearance of a drug or biological product on a quarterly report does […]
On March 20, 2026, the FDA issued a Warning (here) notifying healthcare providers and patients that Carbidopa/Levodopa drug products can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures. The warning instructs healthcare providers to monitor B6 levels in their patients taking the combination therapy, and recommends taking a baseline B6 level at the beginning of treatment. B6 […]
