The FDA released final guidance Tuesday for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on…
FDA Commissioner Scott Gottlieb repeated the agency’s commitment to biosimilars and stakeholders urged the agency to do more to improve market access during a public meeting Tuesday. Source: Drug Industry…
The U.S. District Court for the District of New Jersey issued a permanent injunction barring online distributor Just Enhance from illegally selling sexual enhancement products on more than 100 websites.…
A European Union task force released a two-year plan on Wednesday to prevent or deal with drug shortages in the region. Source: Drug Industry Daily
In the latest CMS move aimed at reducing drug prices, Administrator Seema Verma released new guidance on how Part D plan sponsors can negotiate formulary coverage based on specific indications…
FDA Commissioner Scott Gottlieb announced more recalls Thursday in the FDA’s ongoing investigation into contaminated valsartan products and said the impurity may be a byproduct of the API manufacturing process.…
The FDA called out Indian API manufacturer Vamsi Labs for failing to complete investigations at its Solapur, Maharashtra facility, including one of API batches shipped to the U.S. Source: Drug…
FDA Commissioner Scott Gottlieb Wednesday said the agency plans to scrap its existing guidance on developing new pain drugs and replace it with guidances designed to promote development of new…
The FDA on Tuesday issued Ascend Therapeutics an untitled letter over misleading claims for its estrogen therapy Estrogel. Source: Drug Industry Daily
Drug sponsors wishing to take part in the FDA’s pilot meeting program to discuss complex innovative trial designs (CIDs) with agency staff may now file meeting requests. Source: Drug Industry…