USA – Pharmaceutical distributors seek two-year delay in DSCSA tracking rules
Pharmaceutical distributors are calling for the US Food and Drug Administration (FDA) to grant a two-year delay enforcing the pharmaceutical tracking provisions of the Drug...
USA – Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda
The US Department of Health and Human Services (HHS) has published its semiannual regulatory agenda that includes rules the Food and Drug Administration (FDA)...
USA – FDA finalizes guidance on drug quality consensus standards recognition program
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday published a final guidance on its process for...
USA – FDA issues draft guidance on reporting manufacturing changes for gene therapies
The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Friday issued a guidance to assist sponsors of cell...
USA – FDA Approves New Drug to Prevent RSV in Babies and Toddlers
Today, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates...
USA – FDA revises IEM drug draft guidance to clarify food standards, use of...
The US Food and Drug Administration (FDA) has issued a revised draft guidance on developing drugs to treat inborn errors of metabolism (IEM) to...
USA – FDA Approves First Nonprescription Daily Oral Contraceptive
Today, the U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy— the first daily oral contraceptive approved for...
USA – Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
Industry stakeholders urged the US Food and Drug Administration (FDA) to postpone its October 2023 deadline for testing drug products for novel nitrosamines, saying...
USA – Postmarketing requirements: FDA drafts guidance on determining non-compliance
The US Food and Drug Administration (FDA) has released a draft guidance for sponsors on how the agency determines an applicant has demonstrated good...
USA – FDA describes agency’s initiatives to accommodate growth in cell and gene therapy...
A US Food and Drug Administration (FDA) official discussed the agency’s recent efforts to spur the development of cell and gene therapies during a...
