FDA Webview
X
latest-news

AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.

latest-news

FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including delays in reporting stolen prescription drugs to the agency.

LATEST NEWS

View All
motusgi
AVID Medical Recalls Organ Recovery Bags

AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.

motusgi
FDA Cites Aurobindo for Drug Supply Security Lapses

FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including delays in reporting stolen prescription drugs to the agency.

motusgi
FDA Flags Deficiencies in Aquestive’s Anaphylm NDA

FDA tells Aquestive Therapeutics that deficiencies have been identified in the company’s NDA for Anaphylm that currently preclude labeling and post-marketing commitments discussions.

motusgi
Fast Track for Alessa’s Prostate Cancer Therapy

FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
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
Read More
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
Read More
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
Read More
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

View All
medical-devices
Read More
Industry Recommendations for BsUFA 4 Reauthorization

A Hyman, Phelps & McNamara CMC regulatory expert lists the initial industry recommendations for improvements to be negotiated in the BsUFA reauthoriza...

medical-devices
Read More
FDA to Review Inovio BLA to Treat RRP

FDA accepts for review an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis.

medical-devices
Read More
Hoeg, Prasad Draw Vaccine Concerns

Two lengthy news service stories raise questions about FDA’s approach to vaccines being espoused by CDER director Tracy Beth Høeg and CBER director Vi...

medical-devices
Read More
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...

FDA General

View All
medical-devices
Read More
Harvard Law Hits User Fees Over ‘Corporate Capture’

A new analysis from Harvard Law School argues that the U.S. drug regulator’s reliance on industry-paid user fees has left the agency vulnerable to bot...

medical-devices
Read More
End-of-December Warning Letters

FDA releases substantive Warning Letters in the last two weeks of December 2025.

medical-devices
Read More
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
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...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
PDUFA Public Meeting for User Fee Reauthorization

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

motusgi
Read More
Generic Drug Fee Program Reauthorization Meeting

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

motusgi
Read More
FDA Withdraws and Reissues 2 Guidances

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

motusgi
Read More
CDER Continues Quality Management Program

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

Human Drugs

View All
motusgi
Read More
FDA Cites Aurobindo for Drug Supply Security Lapses

FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain securi...

motusgi
Read More
FDA Flags Deficiencies in Aquestive’s Anaphylm NDA

FDA tells Aquestive Therapeutics that deficiencies have been identified in the company’s NDA for Ana...

motusgi
Read More
Fast Track for Alessa’s Prostate Cancer Therapy

FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prosta...

motusgi
Read More
FDA Guide Outlines Expectations for Bayesian Trial Designs

A new FDA guidance details how drug developers can appropriately use Bayesian statistical methods in...

Marketing

View All
motusgi
Read More
Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

motusgi
Read More
FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

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

motusgi
Read More
Oversight of Influencer Social Media Posts Hard: Researchers

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

motusgi
Read More
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...

Medical Devices

View All
motusgi
Read More
AVID Medical Recalls Organ Recovery Bags

AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits...

motusgi
Read More
RWE, 510(k) TTD Discussed in MDUFA 6 Reauthorization

At a 12/11/2025 MDUFA 6 reauthorization meeting, FDA presented its views on changes involving using ...

motusgi
Read More
Two Digital Health Guidances Published

FDA publishes digital health guidances relating to low-risk general wellness products and clinical d...

motusgi
Read More
Dexcom Glucose Monitor Software Correction is Class 1

FDA says a recent Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous gluco...