FDA Response Time For DTC Ad Advisory Comments Has Doubled, Agency Says

FDA has increased from two to four weeks the time it takes to return direct-to-consumer broadcast ads with advisory comments due to the enlarged volume of submissions, Division of Drug Marketing, Advertising & Communications Branch Chief Nancy Ostrove, PhD, reported Sept. 13 at a Food & Drug Law Institute conference on "Marketing and Promotion in the New Millennium."

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
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Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.