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13 Observations in Zhejiang Hushai Inspection

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

Active Drug Shortages Still Trending Up

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The American Society of Health System Pharmacists says there were 227 active drug shortages in the second quarter of 2026, trendin...

FDA Reevaluating Makarys Journal Articles, Podium Policies: DeGette

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Rep. Diana DeGette (D-CO) wins FDA assurances that several policy announcements issued during former commissioner Marty Makary's t...

Alvotech EF FDA-483 Released

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

Court Backs FDA, Medtronic in Stimulator Suits

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

CDER Planning 85 New, Revised Guidances

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

FDA OKs Merck's Oral PCSK9 Inhibitor for Lowering Cholesterol

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

Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes

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Kalshi launches a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and ...

Nihon Kohden Marketing Adulterated, Misbranded Devices: FDA

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

Hearing Highlights Concerns Over Biomedical Innovation Growing in China

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