USA – Experts: Give FDA authority to remove ineffective drugs
The FDA is struggling to remove drugs from the marketplace that don’t show effectiveness in late stage trials, new JAMA analyses found, thanks to...
USA – FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants
Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent...
USA – Generic drugmakers seek clarity on pre-submission facility correspondence
Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic...
USA – FDA finalizes neurodegenerative disease gene therapy guidance
The US Food and Drug Administration (FDA) last week finalized guidance to assist sponsors developing human gene therapy (GT) products for neurodegenerative diseases. In...
USA – Convergence: Psychedelic drug development is ‘hot,’ but proceed with caution
Psychedelic drug development is receiving more attention lately as these treatments offer the potential for needed therapeutic alternatives for various mental health conditions, yet...
USA – Generic drug lobby details extent of US shortages, offers possible solutions
The Association for Accessible Medicines (AAM) has issued a white paper urging the US Food and Drug Administration (FDA) and other policymakers to adopt...
USA – FDA releases FY 2022 generic drug research summary
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year...
USA – FDA issues final guidance on AML drug development, two oncology draft guidances
The US Food and Drug Administration has published a final guidance and two draft guidances that detail its thinking on developing certain types of...
USA – FDA issues draft guidance of clinical pharmacology, labeling considerations for peptide drug...
The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s clinical pharmacology and labeling considerations for peptide drug products.
When...
USA – FDA updates draft guidance on division-level ANDA disputes
The US Food and Drug Administration (FDA) has published an updated draft guidance explaining how generic drug sponsors can ask for reconsideration of a...
