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...
USA – Omnibus brings new advanced manufacturing programs to FDA
The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing...
USA – FDA finalizes guidance on suspect products under DSCSA
The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that...
USA – FDA proposes long-awaited patient medication information rule
The US Food and Drug Administration (FDA) has proposed new drug labeling requirements to make it easier for patients to understand their medication while...
USA – FDA offers new guidance on therapeutic equivalence evaluations
In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment...
USA – FDA expands bivalent COVID boosters to kids as young as 5
The US Food and Drug Administration (FDA) has updated the emergency use authorizations (EUA) for the bivalent Pfizer-BioNTech and Moderna COVID-19 boosters to expand...
USA – Industry groups seek changes to nonprescription drug access proposal
Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requirements for nonprescription drug products...
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 last guidance in patient-focused drug development series
The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD) guidances meant...
USA – Convergence: FDA looking for ‘a new way forward’ on CBD regulation
The US Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official who...
