Reporters and editors from the Pink Sheet, MedTech Insight and HBW Insight discuss the first 100 days of US Food and Drug Administration Commissioner Robert Califf’s goals, accomplishments, trials and tribulations, across the drug, device and health and wellness sectors and whether ongoing and how crises like the infant formula shortage could affect them. They also consider the potential for lasting change at the agency going forward.
Podcast Special: Assessing US FDA Commissioner Robert Califf’s First 100 Days
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Reporters and editors from the Medtech Insight and sister publications covering the pharmaceutical and health, beauty and wellness sectors look at Califf’s goals, accomplishments and trials during the early days of his second term.
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This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
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Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
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This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
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Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
