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STAT+: Q&A: Califf on obesity drugs, advisory panels, and how threats hurt recruitment at FDA

STAT

BOSTON — FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. Continue to STAT+ to read the full story…

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. She has worked with regulatory agencies and pharmaceutical companies for over 10 years. Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry Draft Guidance.

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Twenty Women Leaders In Healthcare Industry

PharmaShots

Since its launch in 2016, Tivic Health has obtained three regulatory clearances for ClearUP, including FDA 510(k), FDA De Novo, and CE Mark, four patents, and numerous awards. With more than $50 billion in annual global revenue, Janssen has grown to be the second-largest innovative pharmaceutical company under her direction.

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Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence

ISPE

Surrounded by universities and community colleges with life sciences programs, companies in RTP were able to access highly skilled graduates, increasing employment in the state. By the 1990s, pharmaceutical companies were looking to partner with contract research organizations (CROs) for drug development and clinical trials.