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FDA Orders Mfr. Pediatric Studies of Contrast Media

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FDA says it is requiring manufacturers of iodinated contrast media to study the potential for infants to develop underactive thyro...

Another CDRH Letter Challenges Marketing of Test for Consumers

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FDA continues its crackdown against laboratory-developed test makers, sending a letter to HarmonyX about its tests for antiplatele...

Bernie Sanders Grills Califf on Industry Ties

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U.S. presidential hopeful Bernie Sanders (I-VT) grills FDA commissioner-nominee Robert Califf about his relationship with the drug...

ADE Reporting Violations at Heritage Pharmaceuticals

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FDAs New Jersey District Office warns Heritage Pharmaceuticals about violations of Postmarketing Adverse Drug Event Reporting requ...

Misinformation: PhRMA Blasts BMJ Trial Study

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PhRMA says a study on compliance with clinical trial reporting requirements published online by BMJ Open spreads misinformation an...

Alexion Pharma Receives Voucher for Strensiq

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Federal Register Notice: FDA issues a priority review voucher to Alexion Pharmaceuticals for Strensiq, a therapy for infantile- an...

Guidance on Labeling for Drugs Containing Acetaminophen

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Federal Register Notice: FDA releases a guidance: Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug...

FDA Proposes Bacillus Species Detectors into Class 2

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Federal Register Proposed rule: FDA re-proposes to classify in vitro diagnostic devices for Bacillus species (spp.) detection into...

AMA Votes to Support DTC Advertising Ban

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The American Medical Association votes to support a ban on pharmaceutical direct-to-consumer (DTC) advertising.

FDA Guidance on Biosimilar Meeting Requests

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FDA posts a final guidance on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.