FDA Webview
X
latest-news

News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next FDA commissioner.

latest-news

Academic medical center authors writing in the Annals of Internal Medicine say litigation involving the Cook Celect IVC filter demonstrates the need for greater transparency in the regulation of devices cleared through the 510(k) pathway.

LATEST NEWS

View All
motusgi
Johns Hopkins Surgeon Eyed for FDA Top Job

News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next FDA commissioner.

motusgi
Need for Device Transparency Seen in Celect Case

Academic medical center authors writing in the Annals of Internal Medicine say litigation involving the Cook Celect IVC filter demonstrates the need for greater transparency in the regulation of devices cleared through the 510(k) pathway.

motusgi
‘Burdensome’ Device Assessment Guidance: Post

Two medical device experts use a Hyman, Phelps & McNamara post to urge FDA to provide additional guidance to ease what they see as burdensome recommendations in a draft guidance on using chemical characterization to determine medical device biocompatibility.

motusgi
CDRH New Pilot on High-Risk Recalls

CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by companies on high-risk recall issues.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
Animal Drug Regs Amended to Reflect Approvals

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug-related applications.

medical-devices
Read More
Elanco Gets Anti-Itch Zenrelia Approved for Dogs

FDA approves Elanco Animal Health’s Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for controlling itching associated with allergic ...

medical-devices
Read More
CVM Draft Guide on CMC Technical Section

FDA releases a CVM draft guidance entitled “Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.”

medical-devices
Read More
FDA Publishes 2 Revised VICH Guidances

FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures for veterinary drugs.

Biologics

View All
medical-devices
Read More
Preserve Covid-19 Vaccine Records: Senator

Republican Sen. Ron Johnson orders FDA, HHS, and CDC to preserve all records relating to Covid-19 vaccines, saying they will be subpoenaed if they are...

medical-devices
Read More
Cell/Gene Therapy Guide on Common Questions

FDA posts a draft guidance entitled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.”

medical-devices
Read More
Dupixent Supplemental BLA Filed for Urticaria

FDA accepts for review a Sanofi and Regeneron supplemental BLA resubmission for Dupixent (dupilumab) for treating chronic spontaneous urticaria.

medical-devices
Read More
Adaptimmune Therapeutics Plan Lete-Cel BLA

Adaptimmune Therapeutics plans a rolling BLA submission for cell therapy lete-cel in certain people with synovial sarcoma or myxoid/round cell liposar...

FDA General

View All
medical-devices
Read More
Johns Hopkins Surgeon Eyed for FDA Top Job

News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next FDA commissioner.

medical-devices
Read More
RFK Jr. Aims to ‘Free FDA from Corporate Capture’

HHS secretary-nominee Robert F. Kennedy Jr. vows to “free the agencies,” including FDA, “from the smothering cloud of corporate capture.”

medical-devices
Read More
Trump Taps RFK Jr. as HHS Secretary

President-elect Donald Trump picks controversial FDA critic and vaccine skeptic Robert F. Kennedy Jr. as his secretary for Health and Human Services.

medical-devices
Read More
Disappointed Califf on Possible Disruption at FDA

FDA commissioner Robert Califf tells Friends of Cancer Research’s annual meeting that he is “personally disappointed” in the election results and the ...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
Guide on 510(k) Third-Party Reviews

Federal Register notice: FDA makes available a final guidance entitled “510(k) Third Party Review Pr...

motusgi
Read More
IC-Green Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Renew Pharmaceuticals’ IC-Green (indocyanine green) was...

motusgi
Read More
FDA Revokes EUAs on Covid Tests

Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Cue Health for the C...

motusgi
Read More
FDA Provides More Draft ANDA-Specific Guidances

Federal Register notice: FDA makes available additional draft and revised draft product-specific gui...

Human Drugs

View All
motusgi
Read More
MXBBB Recalls Umary Hyaluronic Acid Tablets

FDA says MXBBB has recalled one lot of Umary hyaluronic acid caplets that contain undisclosed diclof...

motusgi
Read More
Fludarabine Phosphate Labeling Changes OKd

FDA announces approved labeling changes for Sandoz’ fludarabine phosphate injection under the Oncolo...

motusgi
Read More
Sage Ending Dalzanemdor Development

Sage says it is ending dalzanemdor development in Huntington’s disease cognitive impairment followin...

motusgi
Read More
CDER Deputy Throckmorton Retiring in January

CDER deputy director for regulatory programs Doug Throckmorton announces his retirement after 27 yea...

Marketing

View All
motusgi
Read More
New DTC Major Statement Standards Become Effective

New FDA advertising standards require drug marketers to ensure their direct-to-consumer advertisemen...

motusgi
Read More
‘False or Misleading’ Xeomin Promotion: FDA

FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring ...

motusgi
Read More
FDA to Study Adherence and Patient Preference in Ads

FDA says the CDER Office of Prescription Drug Promotion will research how consumers and primary care...

motusgi
Read More
FDA to Study Drug Promotion in Talk Shows

The CDER Office of Prescription Drug Promotion says it will research how using an endorser to provid...

Medical Devices

View All
motusgi
Read More
Need for Device Transparency Seen in Celect Case

Academic medical center authors writing in the Annals of Internal Medicine say litigation involving ...

motusgi
Read More
‘Burdensome’ Device Assessment Guidance: Post

Two medical device experts use a Hyman, Phelps & McNamara post to urge FDA to provide additional gui...

motusgi
Read More
CDRH New Pilot on High-Risk Recalls

CDRH says a new device recall pilot program aims to improve communication timeliness about correctiv...

motusgi
Read More
FDA Clears Ultromics EchoGo Amyloidosis Device

FDA clears an Ultromics 510(k) for the EchoGo Amyloidosis for detecting cardiac amyloidosis.