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Suggestions for HDE Draft Guidance Changes

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Four stakeholders give FDA input on a draft humanitarian device exemption guidance.

FDA Veterinary Medicine Opioid Resources

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FDA issues new resources for veterinarians to help them understand opioid problems in the context of a veterinary practice.

FDA Approves Expanded Use for Vertex Kalydeco

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FDA approves Vertex Pharmaceuticals Kalydeco (ivacaftor) to include use in children with cystic fibrosis ages 12 to 24 months who ...

FDA Approves Grifols Zika Virus Assay

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FDA approves Grifols Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors....

Westminster Pharmaceuticals Recalls Thyroid Drugs

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Westminster Pharmaceuticals recalls all lots, within expiry, of its thyroid drugs levothyroxine and liothyronine because they were...

Joint Advisory Panel to Discuss Modernizing Drug Assessments

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Federal Register notice: FDA announces a 9/20 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting that wil...

CDERs Patrick Frey Leaving for Amgen

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Office of New Drugs (OND) chief of staff Patrick Frey announces his departure to join Amgen as Global Regulatory Policy and R&D di...

FDA, NIH Reducing Regulatory Oversight of Gene Therapy Trials

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FDA and NIH propose to relax some oversight of gene therapy trials to help expedite product development.

Comment Period Reopened on Animal Drug Impurities

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Federal Register notice: FDA reopens the comment period on a draft guidance entitled Elemental Impurities in Animal Drug Products ...

Joint FDA Panel Looks at Modernizing NDA Assessments

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FDA announces a 9/20 advisory committee meeting to discuss modernizing its NDA assessments through a Knowledge-Aided Assessment an...