A new FDA draft guidance the over-the-counter (OTC) monograph drug user fee program outlines the program’s features and procedures, including the types of fees, due dates, the process for submitting…
The FDA has revised its October 2017 draft guidance on the Expanded Access program, adding information on eligibility criteria, submission process and safeguards intended to protect patients and preserve the…
Use of FDA’s expedited approval pathways for new drugs increased from 42 percent in 2008 to more than 75 percent in 2021 — an increase that’s likely to continue as…
The FDA has issued a Deferred Action letter for Amicus Therapeutics’ biologic license application (BLA) for cipaglucosidase alfa, the biologic component of AT-GAA, its investigational dual therapy for muscle-wasting Pompe…
In a draft guidance released today, the FDA says trials of drugs for pediatric use should train clinical investigators and trial staff to measure and evaluate the drug’s potential impact…
Due to a provision in the recently passed Inflation Reduction Act (IRA), Alnylam Pharmaceuticals won’t be conducting a phase 3 trial of its RNAi therapeutic to treat the rare eye…
The FDA clarifies its regulatory requirements for small entity establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/P), in a final guidance released today. Source: Drug Industry…
The FDA has declined to green-light Gilead Sciences’ hepatitis delta virus (HDV) drug bulevirtide because of manufacturing and delivery concerns, meaning there will continue to be no approved treatment for…
Older people, smokers and those with an increased risk of cardiovascular problems shouldn’t use Janus kinase inhibitors for chronic inflammatory diseases unless there are no other suitable treatment options, according…
The FDA has rejected a citizen petition pressing the agency to revoke the accelerated approval for Jazz Pharmaceuticals’ and PharmaMar’s Zepzelca (lurbinectedin), a treatment for adults with metastatic small cell lung…