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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...

Medical Devices

Nihon Kohden Marketing Adulterated, Misbranded Devices: FDA

FDA warns Irvine, CA-based Nihon Kohden Digital Health Solutions that it is marketing an adulterated and misbranded unapproved medical device.

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Human Drugs

Hearing Highlights Concerns Over Biomedical Innovation Growing in China

Witnesses at a House Energy and Commerce Health Subcommittee hearing urge lawmakers to modernize the nation's clinical trial system, and strengthen FD...

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Human Drugs

House Hearing Previews Debate Over FDA Modernization, User Fees

House Energy and Commerce Health Subcommittee leaders reveal differing views over whether the Trump administration's policies are strengthening or und...

A New Era of Innovation for FDA Public Health Pillars

FDA acting commissioner Kyle Diamantas positions the agencys four public health pillars as a means to fulfill its enduring mission in a new era.

Human Drugs

VAI Close Out for HLB Inspection

A Cancer Network post says FDA issued a voluntary action indicated close-out letter to HLB following a CGMP inspection at a facility manufacturing the...

Kennedy Wanted Sentinel, BEST Data: Reuters

A Reuters deep dive into HHS secretary Robert F. Kennedy Jr.s efforts to eliminate childhood vaccine requirements says his aides asked FDA for access ...

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EIRS/483s

Priority Review for Gazyva sBLA for Primary Membranous Nephropathy

FDA grants Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with primary membranous nep...