Drugs

DSCSA Waiver, Exception, Exemption Guidance

FDA has published a guidance, Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, describing how an authorized trading partner or other stakeholder should request a waiver, exception, or exemption from the Drug Supply Chain Security Act (DSCSA). The document also describes the factors FDA will consider when evaluating such requests and when determining FDA-initiated exceptions and exemptions.

The guidance further describes the process FDA says it intends to follow every two years to review and make determinations on the appropriateness of renewing a previously approved waiver, exception, or exemption, where applicable.

The document finalizes a 05/2018 draft guidance and updates the policy articulated in that draft.

It contains an Introduction; Background; Process for Submitting Waiver, Exception, or Exemption Requests to FDA; Process for Reviewing and Determining Waiver, Exception, or Exemption Requests; Process for FDA-Initiated Exceptions and Exemptions; Review and Renewal of Waiver, Exception, and Exemption Requests; and an Appendix.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome