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Medical Devices

Class I Recall of Bolton Medicals Relay Pro Thoracic Stent Graft System

Bolton Medical recalls its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death.

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Human Drugs

FDA Cites Charles River Endosafe Lab Over Quality System Deficiencies

FDA issues a Form-483 to Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies...

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Marketing

Friendly Accelerated Approval Disclosures Improve Drug Understanding: Study

A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated approvals when disc...

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Human Drugs

13 Observations in Zhejiang Hushai Inspection

FDA releases the form FDA-483 with 13 observations from an April inspection at Chinas Zhejiang Hushai Pharmaceutical Co.

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Human Drugs

Active Drug Shortages Still Trending Up

The American Society of Health System Pharmacists says there were 227 active drug shortages in the second quarter of 2026, trending up for the third q...

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Human Drugs

FDA Reevaluating Makarys Journal Articles, Podium Policies: DeGette

Rep. Diana DeGette (D-CO) wins FDA assurances that several policy announcements issued during former commissioner Marty Makary's tenure including art...

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Human Drugs

Alvotech EF FDA-483 Released

FDA releases the form FDA-483 with five observations from an inspection at Icelands Alvotech EF.

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Medical Devices

Court Backs FDA, Medtronic in Stimulator Suits

MassDevice reports a Minnesota federal judge gave significant victories to Medtronic and FDA in four cases involving the companys spinal cord stimulat...

Human Drugs

CDER Planning 85 New, Revised Guidances

FDA publishes the latest CDER guidance agenda showing plans for 85 new or revised guidances to be issued in 2026.

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Human Drugs

FDA OKs Merck's Oral PCSK9 Inhibitor for Lowering Cholesterol

FDA approves Merck's Lipfendra (enlicitide) 20 mg tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in certain ...