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Breakthrough Therapy Designation for 2 New Alzheimers Drugs

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FDA grants breakthrough therapy designations to Alzheimers drugs being developed by Lilly and Eisai/ Biogen.

Sterile Drug Compounding Deficiencies at Roger Williams Center

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FDA issues a notice of violation to the Roger Williams Medical Center Oncology Pharmacy Clinic relating to deficiencies in the pre...

Oticon PMA Approved for Cochlear Implant

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FDA approves an Oticon Medical PMA for the companys Neuro System, a cochlear implant for treating individuals 18 years or older wi...

Ex-FDAer Laughren Joins Cybin Advisory Board

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Retired FDA psychiatry products director Thomas Laughren joins Cybin as a clinical advisory board member.

Company Selling Illegal New Drugs for Humans and Animals: FDA

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FDA warns Fresh Nutrition it is selling misbranded and unapproved new human and animal drugs.

Regulatory Review Determined for Turalio

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyos Turalio (pe...

2 Observations in Venus Concept FDA-483

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FDA releases an FDA-483 with two observations from an inspection at Venus Concept.

New FDA Documents Shed Light on Biogen Approval

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New FDA-posted review documents provide more insight into how FDA reconciled using the accelerated approval pathway for Biogens Al...

Fewer Inspections Can Cause Manufacturing Errors: Professors

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Two University of Connecticut professors say it will take a long time for FDA to recover from drug manufacturing inspections that ...

FDA Can Help CMS with Hospital Cybersecurity: OIG

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The HHS Inspector General says the Center for Medicare and Medicaid Services should work with FDA and other partners to find the b...