USA – FDA finalizes enforcement policy for FMT treatments
In a newly finalized guidance, the US Food and Drug Administration (FDA) laid out its criteria for applying enforcement discretion for new fecal microbiota...
USA – FDA’s top 10 tips to transition your COVID-19 products
During the COVID-19 pandemic, the US Food and Drug Administration (FDA) allowed more than 4,000 medical devices and diagnostics on the market under emergency...
USA – FDA releases guidance on compounding beta-lactam products in shortage
The US Food and Drug Administration (FDA) has released a new guidance with immediate effect outlining its enforcement policy for preparation of certain beta-lactam...
USA – FDA Approves First Gene Therapy to Treat Adults with Hemophilia B
Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia...
USA – Industry asks FDA to align quantitative labeling guidance with other regulators
Pharmaceutical manufacturers said the US Food and Drug Administration (FDA) draft guidance specifying quantitative labeling recommendations for sodium, potassium and phosphorus in human over-the-counter...
USA – Most FDA warning letters this year from onsite inspections
A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year...
USA – FDA approves first drug to delay onset of type 1 diabetes
The company submitted positive results from the randomised, double-blind, placebo-controlled TN-10 trial that included 76 patients with stage 2 type 1 diabetes.
Results showed that,...
USA – FDA relaxes EUA advertising limitation for some COVID drugs
The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs)....
USA – FDA Adds/Revises Product-Specific Guidances
The FDA has issued 29 new product-specific draft guidances and 22 revised draft guidances for complex and non-complex generic drug products.
The guidances provide product-specific...
USA – Stakeholders ask FDA to harmonize adverse events terms with standards orgs
Pharmaceutical companies are asking the US Food and Drug Administration (FDA) for more adverse events reporting standardization by harmonizing with standards organizations as well...
