USA – FDA issues draft guidance on mpox drug development
In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot...
USA – Study: Extrapolation used in more than half of pediatric drug labeling changes
Some form of data extrapolation – either full or partial – was used in making more than 63% of pediatric labeling changes in the...
USA – FDA revises IEM drug draft guidance to clarify food standards, use of...
The US Food and Drug Administration (FDA) has issued a revised draft guidance on developing drugs to treat inborn errors of metabolism (IEM) to...
USA – FDA exploring model master files to expedite generic drug development
The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling...
USA – FDA allows sponsors to spread out costs in revised IND charging guidance
The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for...
USA – Pfizer: le spray nasal anti-migraine approuvé par la FDA
Pfizer a annoncé vendredi que la Food and Drug Administration (FDA) américaine avait approuvé le Zavzpret, son spray nasal pour le traitement de la...
USA – Global Pharma’s eye drops contaminated with “filth” while Amazon made unapproved claims...
The US Food and Drug Administration (FDA) lambasted India-based Global Pharma Healthcare in a 14 November warning letter for manufacturing eye drops that have...
USA – FDA issues draft guidance on post-warning letter meetings under GDUFA III
The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified...
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...
