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FDA/FTC's Hot Ticket: Biosimilar Workshop On How To Boost Market, From Education To Lawsuits

Executive Summary

Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.

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The rapid pace with which inaccurate information can spread on social media may necessitate loosening some of FDA’s regulations on sponsors to let them respond, Commissioner Robert Califf said at the J.P. Morgan Healthcare Conference. Califf also worried about how legitimate debate can undermine public confidence in FDA.

US FDA Mulls Granting Regulated Industry Flexibility To Respond To Misinformation

The rapid pace inaccurate information spreads on social media may necessitate loosening some of FDA’s regulations to let sponsors respond, Commissioner Robert Califf said at J.P. Morgan Healthcare Conference. Califf also worried about how legitimate debate can undermine public confidence in FDA.

US FDA Mulls Granting Regulated Industry Flexibility To Respond To Misinformation

The rapid pace with which inaccurate information can spread on social media may necessitate loosening some of FDA’s regulations on sponsors to let them respond, Commissioner Robert Califf said at the J.P. Morgan Healthcare Conference. Califf also worried about how legitimate debate can undermine public confidence in FDA.

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