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Device Guidance on Voluntary Improvement Program

[ Price : $8.95]

FDA releases a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Impr...

Myovant, Pfizer Myfembree sNDA Review Extended

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Citing the need to assess just-submitted bone mineral density data, FDA extends its review of a Myovant Sciences and Pfizer supple...

Diabetes Device Feasibility Studies Guidance

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Federal Register notice: FDA makes available a final guidance entitled Feasibility and Early Feasibility Clinical Studies for Cert...

Increase FDA Oversight of Lab-developed Tests: Pew

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A new Pew Charitable Trusts survey on lab-developed tests finds that most participants would favor increased FDA oversight in this...

Califf Returned to FDA for Unfinished Business

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FDA commissioner Robert Califf admits that his return to the FDA top post gives him an opportunity to address unfinished business ...

Lasik Injury Advocate Steps Up Pressure on Illegal Ads

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Lasik injury advocate and Vision Advocacy president Paula Cofer steps up pressure to get FDA commissioner Robert Califfs attention...

CDER Study Verifies Continuous Manufacturing Benefits

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Eleven CDER staffers say a Center self-audit of continuous manufacturing regulatory submissions verifies the benefits the agency h...

FDA Approves Enhertu for Some Additional Breast Cancers

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FDA approves a new indication for Daiichi Sankyos Enhertu for some breast cancer patients.

Switching Generic Levothyroxine Maintains Thyroid Function: Study

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FDA-sponsored research demonstrates that patients who switch between generic levothyroxine products maintain the same level of thy...

15 Observations in Qualgen FDA-483

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FDA releases the FDA-483 with 15 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing facility.