USA – FDA updates guidance on expanded access for investigational drugs under IND
The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug...
USA – Stakeholders seek flexibility, greater harmonization in FDA human subject protection rules
Commenters from the pharmaceutical and medical device industries, academia and medical groups urged the US Food and Drug Administration (FDA) to help ease the...
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Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic...
Canada – Guidance : Nitrosamine impurities in medications
This guidance represents Health Canada's current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to...
USA – FDA issues long-awaited LDT final rule
After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan...
USA – FDA releases 5-year action plan to combat neurodegenerative diseases
The FDA on June 23 announced a 5-year strategy for improving and extending the lives of people with rare neurodegenerative diseases by advancing development...
USA – OIG raises concerns about accelerated approval pathway
More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years...
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 officials impart lessons learned from quality management maturity pilots
The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or...
USA – FDA issues guidance on submission of pharmacogenomic data
The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory...
