During a Zoom event on Tuesday, June 12th, Food and Drug Administration (FDA) Commissioner Robert Califf told members of the Alliance for a Stronger FDA that the agency would promote the development of new evidence generation systems. Califf remarked that the US had fallen behind in evidence […]
Vin Gupta in the Lead for FDA Medical Advisor Role
The US Food and Drug Administration (FDA) is looking for a new principle medical adviser to take charge of public messaging after a series of foibles that have shaken public trust in the agency. Top in the running is Vin Gupta, a pulmonologist who regularly discusses public health on MSNBC and […]
FDA Gives Amylyx’s ALS Drug a Second Chance
Amylyx’s application for its ALS drug was narrowly shot down by FDA advisors earlier this year because they were not satisfied with the evidence provided. Fortunately for the biotech, the FDA has agreed to discuss the application again on September 7th. According to , “But the move to call […]
Fagron Group API Facility Receives FDA Warning Over Cleaning Issues
The US Food and Drug Administration (FDA) has issued a warning letter to an active product ingredient (API) facility run by the Netherlands-based Fagron Group. A key accusation was that an employee destroyed cleaning logs, an act deemed more egregious due to the company’s previous issues with the […]
New FDA Proposal Would Expand Access to Nonprescription Medications
A new proposal by the FDA lays out new requirements to expand the use of a non-prescription drug to additional conditions while maintaining non-prescription status. If the agency finds that a product’s labeling is too unclear, drugmakers can set conditions for non-prescription use instead of making […]
FDA Will Present Draft Guidance on Real-World Evidence in Grand Rounds on June 22nd
The US Food and Drug Administration will unveil its highly anticipated draft guidance on real-world evidence this Friday, June 24th. The grand rounds session begins at 1:00 PM EST and will be presented by Dr. John Concato. According to Rethinking Clinical Trials, “Dr. Concato is the associate […]
Breaking: US FDA Approves Moderna and Pfizer’s COVID-19 Vaccines for Children 5 and Under
The US Food and Drug Administration’s (FDA) vaccine advisory committee (Adcomm) voted unanimously (21-0) to approve Moderna and Pfizer’s mRNA-based COVID-19 vaccines for children aged 5 and under. The anticipated approval was urged by many in the healthcare community due to the increasing numbers of […]
FDA Vocalizes Support for Moderna and Pfizer Vaccines for Children Under 5 One Day Before Advisory Committee
The US Food and Drug Administration (FDA) has signalled support for authorizing the Moderna and Pfizer COVID-19 vaccines for children under the age of 5 just one day before the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is set to meet. The recommended authorization […]
CMC – Gene Therapy’s “Achilles Heel”
Patient access to novel gene therapies is often obstructed by manufacturing challenges, in particular, issues with Chemical, Manufacturing and Controls (CMC). With increasing scrutiny from health technology assessment (HTA) agencies, biopharma companies must establish excellent and transparent CMC […]
Novavax COVID-19 Vaccine Awaits FDA Review of Manufacturing Data
On Tuesday, outside experts at the US Food and Drug Administration (FDA) voted 21 – 0 to give emergency approval to Novavax’s COVID-19 vaccine. Unlike every other approved COVID-19 vaccine, however, the company’s vaccine has yet to be formally approved by the agency two days later. The other […]
