Manufacturers and importers of iron-containing vitamin supplements and OTC products must immediately comply with a law requiring certification of child-resistant packaging, the Consumer Product Safety Commission says in a final 1rule issued Nov. 10. Under the Consumer Product Safety Improvements Act, any packaged product containing 250 mg or more of elemental iron starting Nov. 12 needs to certify compliance with the Poison Prevention Packaging Act. Though CPSIA was enacted in August, industry stakeholders say they were not aware it would apply to food, drugs and cosmetics until CPSC clarified it Oct. 2 (2"The Tan Sheet" Nov. 10, 2008, p. 10). The final rule says enforcement will focus "more on the substantive requirements underlying the certificate than on the certificate or the form of the certificate itself," until Congress addresses CPSC's "resource limitations." The rule also confirms electronic certificates are appropriate. The Council for Responsible Nutrition and the Consumer Healthcare Products Association say CPSC did not respond to the trade groups' requests for more time and flexibility
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
