2023

 

March 24- FDA posts “Clinical Trial Considerations To Support Accelerated Approval of Oncology Therapeutics; Draft Guidance for Industry; Availability.”
“Given the limitations of single-arm trials, a randomized controlled trial is the preferred approach to support an application for accelerated approval,” the FDA staff writes.

In a comment on this draft, PhRMA encouraged FDA to consider providing examples in the final guidance of when a single-arm trial approach would be most appropriate such as when an RCT would raise ethical concerns.

The FDA staff also acknowledges the challenges in designing trials in a rapidly emerging field. Accelerated approval is intended to speed sales of medicines that considered likely to offer meaningful alternatives to those already on the market. The FDA in these cases makes a calculated decision, weighing risks and uncertainties against possible benefits. In some cases, the standard of care may chance during drug testing.

“Ultimately, the determination of what constitutes available therapy is made at the time the regulatory decision is made rather than at the time the trial was initiated,” the FDA staff wrote.

Jan. 18. FDA opens nonrulemaking docket, titled Advancing Real-World Data and Real-World Evidence with User Fee Funding (FDA-2023-N-0156)

2021

2021- August 23: The FDA granted a regular approval for the Pfizer-BioNTech vaccines in people ages 16 and older.

2021-Aug. 5. ICER issues final report on aducanumab. (Cut Aducanumab Cost, Speed Confirmatory Research, ICER Says Medscape Medical News.)

2021-Aug. 4 OIG announces review of FDA accelerated review process. (FDA’s Accelerated Drug Approval Process Under Investigation by OIG, Aug. 5, 2021. Medscape Medical News.)

2021-July 15 ICER panel finds no net benefit to aducanumab (No Net Benefit of Aducanumab for Alzheimer’s Disease, Expert Panel Rules, July 16, 2021. Medscape Medical News.)

2021-July 12. CMS announces national coverage analysis for aducanumab. ( Contentious Alzheimer’s Drug Likely to Get National Coverage Plan, CMS Says, July 13, 2021. Medscape Medical News. )

2021-June 7. FDA approves aducanumab

2020

2020-Nov. 6. FDA advisors essentially voted against approval of this drug. (FDA transcript of meeting)

 

2020

The FDA issues the first EUA for a COVID-19 vaccine.

2005

January 7- The FDA issues the first EUA.

2011

Nov. 28- St. Jude Medical initiates Class I recall of Riata products. The company confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors.

2004

 

1996

September 6- FDA issues accelerated approval for midodrine in hypotension. As of 4/21/22, the FDA listed this accelerated approval as “not yet converted.” (FDA letter on midodrine)

1992

April 15 – FDA publishes in the Federal Register a draft rule for accelerated approvals.( See a copy of the Federal Register notice here, FR-1992-04-15.) 

1906

President Theodore Roosevelt signs into law the Food and Drugs Act, which sought to prevent sales of dangerous substances branded as medicine.