Latest News & Analysis
'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.
Expert investigators found many problems at Ahmedabad plant, warning letter and Form 483 report show.
Acting Commissioner Giroir Emphasizes 'Transitional' Period, Suggesting Time At US FDA Will Be Short
Giroir's memo to FDA staff also says intends to coordinate with prior acting commissioner Norman Sharpless to ensure current activities continue.
US FDA's wariness of taking enforcement action against Rx drug promotions may lead to more suits like GSK's. Complaint says healthcare providers are switching COPD patients to BI's Respimat inhaler in response to BI's marketing campaign.
Despite FDA's concerns, advisory committee unanimously endorses Vascepa's labeling expansion, with 10 of 16 members also favoring approval for secondary as well as primary prevention even as several voiced misgivings about efficacy in the REDUCE-IT trial's lower risk cohort.
Francis Arickx from the cross-country coalition BeNeLuxA spoke this month about how the initiative had delivered proof of concept and discussed why uniting across borders is important for delivering access to transformative but expensive medicines.
The Italian health ministry is looking for someone to take over as director general of the medicines agency AIFA. The move has shocked health activists who see Luca Di Bassi as a champion of drug price transparency.
ViiV Healthcare has asked the European Medicines Agency to accelerate its review of fostemsavir when the company files for pan-EU market approval of the product.
Rigel Pharmaceuticals and Jazz Pharmaceuticals are among the companies that could find out this week whether their new drug applications at the European Medicines Agency are likely to be approved for marketing across the EU. The EMA's key scientific committee, the CHMP, will also consider applications from Roche and Novartis.
Expanded indication for type 1 diabetes seems out of reach for the moment, but if Boehringer conducts a larger and lengthier trial, it could eventually persuade members of the Endocrinologic and Metabolic Drugs Advisory Committee who voted 14-2 against supplemental approval of empagliflozin for the proposed 2.5mg dose.
FDA says 16% of ANDAs have an issue with "hidden facilities" that are listed in drug master files but not the ANDAs they are linked with; industry official offers some tips to bridge this communications gap with DMF holders.
US FDA's reorganization of drug reviews splits Keegan's old OHOP division into two.
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