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FDA Reevaluating Makary’s 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 articles published in medical journals and media interviews— are not intended to be recognized as official agency guidance.

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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 quarter in a row.

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Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes

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Human Drugs

FDA OKs Merck's Oral PCSK9 Inhibitor for Lowering Cholesterol

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Human Drugs

CDER Planning 85 New, Revised Guidances

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Human Drugs

FDA Reevaluating Makary’s Journal Articles, Podium Policies: DeGette

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FDA Reevaluating Makary’s 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 articles published in medical journals and media interviews— are not intended to be recognized as official agency guidance.

motusgi
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 quarter in a row.

motusgi
Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes

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

motusgi
13 Observations in Zhejiang Hushai Inspection

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

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Animal Drugs

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Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

medical-devices
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FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA authorizes Felix Pharmaceuticals’ generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

Biologics

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medical-devices
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Blood Donor Screening in an Ebola Outbreak

FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in response to an Ebola ...

medical-devices
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Former CDC Official Alleges Political Interference In Vaccine Policy

During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no longer defend its sci...

medical-devices
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FDA Accepts Replimune's Resubmitted BLA for Advanced Melanoma

FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolu...

medical-devices
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EC Opens Antitrust Probe into Sanofi's Flu Vaccine Marketing

The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misle...

FDA General

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medical-devices
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Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes

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

medical-devices
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Yale, Harvard Experts Call for Greater FDA Transparency To Rebuild Public Trust

A group of academic and public health experts urges FDA to embrace greater transparency, scientific independence and regulatory consistency, arguing t...

medical-devices
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White House Looking at 3 Possible FDA Commissioners: Reports

Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.

medical-devices
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FDA Plans Rule to Require Full Risk Info in Drug Ads

FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, radio and similar broad...

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Federal Register

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FDA Moves to Cement Complete Response Letter Transparency Policy

FDA looks to formalize one of its most significant transparency initiatives in decades: the public r...

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

Human Drugs

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FDA Reevaluating Makary’s Journal Articles, Podium Policies: DeGette

Rep. Diana DeGette (D-CO) wins FDA assurances that several policy announcements issued during former...

motusgi
Read More
Active Drug Shortages Still Trending Up

The American Society of Health System Pharmacists says there were 227 active drug shortages in the s...

motusgi
Read More
13 Observations in Zhejiang Hushai Inspection

FDA releases the form FDA-483 with 13 observations from an April inspection at China’s Zhejiang Hush...

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Alvotech EF FDA-483 Released

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

Marketing

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DTC Advertising Industry Braces for Potential End of Adequate Provision

DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provi...

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FDA Cites Lundbeck Over Vyepti Promotional Claims

FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials...

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FDA Sued Over Rejection of Supplement Ad Claims

Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for...

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FDA Cites QOL Medical for Misleading Promotion of Sucraid

FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease ...

Medical Devices

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Court Backs FDA, Medtronic in Stimulator Suits

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

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Nihon Kohden Marketing Adulterated, Misbranded Devices: FDA

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

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Multiple Violations in ZIIP Inspection

FDA warns Pleasant Hill, CA-based ZIIP Inc. about Quality System violations in its production of adu...

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BlephEx 12-Page Warning Letter

FDA warns Brentwood, TN-based BlephEx about multiple violations in its manufacturing of three unappr...