USA – FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
USA – FDA Adds/Revises Product-Specific Guidances
The FDA has issued 29 new product-specific draft guidances and 22 revised draft guidances for complex and non-complex generic drug products.
The guidances provide product-specific...
USA – FDA and CDC investigate potential safety concern for Pfizer/BioNTech’s COVID-19 vaccine
The investigation was prompted by preliminary data from the CDC’s vaccine safety monitoring system, which raised a question of whether people aged 65 years...
USA – FDA revises guidance on electronic systems and signatures in clinical trials
The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials. While the...
USA – FDA finalizes guidance on adjusting for covariates in randomized trials
The US Food and Drug Administration (FDA) on Friday released a final guidance addressing how sponsors can adjust for covariates in analyzing randomized clinical...
USA – FDA to form task force, public-private partnership on rare neurodegenerative diseases
The US Food and Drug Administration (FDA) released a five-year action plan for accelerating drug development for rare neurodegenerative diseases, such as amyotrophic lateral...
USA – FDA releases discussion paper on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and...
USA – FDA revises ANDA facility correspondence draft guidance
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking...
USA – DSCSA: New interoperability ‘blueprint’ released
With less than a year remaining before the Drug Supply Chain Security Act (DSCSA) takes full effect, an industry consortium has published new chapters of a...
USA – FDA withdraws pre-term birth drug Makena
Two-and-a-half years after it first proposed doing so, the US Food and Drug Administration (FDA) has made a final decision to immediately withdraw Makena...
