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FDA Cybersecurity Modernization Action Plan

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Two FDA information technology executives describe the agencys new cybersecurity modernization action plan.

Comments Sought on Proposed NDC Revision

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CDER lead consumer safety officer Leyla Rahjou-Esfandiary says the agency wants to receive comments by 11/22 on its proposal to in...

FDA Warns 7 Supplement Companies About CV Claims

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FDA warns seven dietary supplement manufacturers they are illegally selling products that claim to treat cardiovascular disease.

FDA Approves Lilly Interchangeable Insulin Product

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FDA approves Lillys Rezvoglar as the second interchangeable biosimilar insulin product.

9 Senators Want FDA Medication Abortion Action

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Nine Democratic senators ask FDA to take three steps to protect and expand access to medication abortions.

Advisors Back Ardelyx Kidney Disease Drug

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Members of the FDA Cardiovascular and Renal Drugs Advisory Committee vote to recommend approval of Ardelyx tenapanor for a kidney ...

Pfizer/BioNTech Studying Next Gen Covid Vaccine

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Pfizer and BioNTech begin a Phase 1 study of their next-generation Covid-19 vaccine that they say is designed to enhance SARS-CoV-...

Pazdur Puts Foot Down on Single Country Trials

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FDA Oncology Center of Excellence director Richard Pazdur says data from multiregional trials that represent the major Internation...

FDA Planning White Oak Return Under Hybrid Approach

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FDA commissioner Robert Califf and Oncology Center of Excellence director Richard Pazdur endorse a return of FDA employees to the ...

Class 1 Recall on Omnipod Insulin Delivery System

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An Insulet recall of its Omnipod DASH Insulin Management System receives a Class 1 recall classification by FDA.