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 – FDA revises guidance on responding to ANDA complete response letters
The US Food and Drug Administration (FDA) has revised its guidance on timeframes for responding to complete response letters (CRL) to abbreviated new drug...
USA – Legal expert: FDA inspections will start looking at DSCSA compliance
Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes...
USA – FDA officials offer CMC advice for gene therapies at OTP town hall
Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged...
USA – FDA proposes master control trial guidance that goes beyond COVID-19
The US Food and Drug Administration (FDA) this week published a draft guidance on the use of master protocols in clinical trials of drugs...
USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
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...
