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The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among public health experts and the biotech industry.

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FDA faces Increased scrutiny of its newly established Commissioner’s National Priority Review voucher program, which is intended to accelerate the review of select drug applications, because of political interference concerns.

LATEST NEWS

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FDA Tumult Keeps Makary Under Microscope: NYT Article

The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among public health experts and the biotech industry.

motusgi
Is Political Pressure Corrupting New FDA Voucher Program?

FDA faces Increased scrutiny of its newly established Commissioner’s National Priority Review voucher program, which is intended to accelerate the review of select drug applications, because of political interference concerns.

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NEWSROOM CLOSED FOR THE HOLIDAYS

FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.

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FDA Guidance on Bioresearch Monitoring Inspections

FDA posts an updated guidance outlining its processes for bioresearch monitoring inspections, which oversee the conduct, reporting, and postmarketing activities of FDA-regulated clinical and nonclinical studies.

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Animal Drugs

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medical-devices
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Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

medical-devices
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10/9 Vaccines Panel to Recommend Flu Strain Selection

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...

medical-devices
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Capsida Pauses Gene Therapy Trial After Death

Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...

medical-devices
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Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Biologics

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medical-devices
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FDA Cites GSK Hungary Vaccine Plant

FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, includ...

medical-devices
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Catalent Issued 2 FDA Form 483s

FDA posts two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc., highlighting ongo...

medical-devices
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Sen. Johnson Seeks FDA Docs on Covid Vaccine Deaths

Sen. Ron Johnson (R-WI) demands that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the deaths of at least 1...

medical-devices
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Makary Says ‘No Plans’ for Covid Vaccine Boxed Warning

FDA commissioner Marty Makary says the agency has “no plans” to add a Black Box Warning to Covid vaccines, contradicting a report from last week say...

FDA General

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medical-devices
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FDA Tumult Keeps Makary Under Microscope: NYT Article

The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among ...

medical-devices
Read More
NEWSROOM CLOSED FOR THE HOLIDAYS

FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.

medical-devices
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Republicans Dismiss RFK Jr. Subpoena Vote for Testimony

House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to testify before Congres...

medical-devices
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FDA Commissioner Defends Vaccine Stance, Transparency Push

In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency actions that have draw...

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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Is Political Pressure Corrupting New FDA Voucher Program?

FDA faces Increased scrutiny of its newly established Commissioner’s National Priority Review vouche...

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FDA Guidance on Bioresearch Monitoring Inspections

FDA posts an updated guidance outlining its processes for bioresearch monitoring inspections, which ...

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AstraZeneca Pulling Andexxa From Market Due to Safety

A new FDA safety update says safety risks associated with AstraZeneca’s Andexxa outweigh the drug’s ...

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FDA Seeks Alternate Path to Fed Contracting for Tech Access

FDA seeks input on a new way to contract directly with venture capital–backed innovators in an effor...

Marketing

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FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

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Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

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Create ‘Drug Facts’ Box for DTC Ads: Column

Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers...

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WLF Wants End to FDA TV Ad ‘Crackdown’

The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising,...

Medical Devices

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FDA Sends Warning Letters to Makers of Breast Binders

FDA begins enforcement actions against companies illegally marketing breast binders to children, pla...

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Medical Device RWE Guidance

FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are suffic...

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GAO Flags Staffing Gaps and Legal Limits With Device Recalls

The Government Accountability Office urges HHS to shore up staffing and reassess legal authorities a...

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‘Exceptional Performance’ of TAP Pilot: Report

An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its...