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McNeil Recalls Liquid Infants’ Tylenol With Dosing Device Problem

 
• By Dan Schiff

McNeil Consumer Healthcare recalls an Infants’ Tylenol product that returned to market in November, after receiving consumer complaints about a problem with the SimpleMeasure dosing device system. The recall marks a misstep in the J&J subsidiary’s comeback from OTC quality control issues.

An apparent defect related to the dosing devicepackaged withanInfants’ Tylenol product promptedMcNeil Consumer Healthcare’s latest liquid pediatric OTC drug recall.

The recall suggests the difficulty pharma firms face in improving OTC dosing accuracy and safety while providing user-friendly dosing systems.

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No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By Sue Sutter

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

UK’s Plan To Become World’s Third Top Life Sciences Economy Falls Short, Says ABPI

 
• By Neena Brizmohun

The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.

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

 
• By Francesca Bruce

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.

More from Compliance

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

 
• By Eliza Slawther

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.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
• By Eliza Slawther

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”