FDA Webview
X
latest-news

FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see transformative treatments — and potentially cures — across a range of serious diseases in the coming years

latest-news

HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has sparked concern among former agency officials and public health experts.

LATEST NEWS

View All
motusgi
FDA Commissioner Outlines Ambitious Vision for Breakthrough Treatments

FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see transformative treatments — and potentially cures — across a range of serious diseases in the coming years

motusgi
HHS Weighs Reversal of FDA Peptide Restrictions Despite Safety Concerns

HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has sparked concern among former agency officials and public health experts.

motusgi
October Deadline for New Adverse Event Reporting Standard

FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for submitting postmarketing safety reports.

motusgi
Context Therapeutics’ Ovarian Cancer Drug Wins Fast Track

FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovarian cancer.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update

A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...

medical-devices
Read More
Partial Hold on Myotonic Dystrophy Type 1 Therapy

FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1.

medical-devices
Read More
FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
Read More
Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

Biologics

View All
medical-devices
Read More
CBER File Over Protest SOPP

CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file decision.

medical-devices
Read More
FDA Accepts Ultragenyx Resubmission for Gene Therapy

Ultragenyx Pharmaceutical refiles a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A. ...

medical-devices
Read More
Kite’s Tecartus for Mantle Cell Lymphoma Gets Full Approval

FDA grants full approval for Kite’s CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell...

medical-devices
Read More
Xbrane Plans Resubmission of Lucentis Biosimilar by June

Xbrane Biopharma says it plans to resubmit a BLA before June for ranibizumab, a biosimilar copy of Genentech’s Lucentis, which is indicated for treati...

FDA General

View All
medical-devices
Read More
FDA Commissioner Outlines Ambitious Vision for Breakthrough Treatments

FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see transformative treatm...

medical-devices
Read More
HHS Weighs Reversal of FDA Peptide Restrictions Despite Safety Concerns

HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has spa...

medical-devices
Read More
Makary Signals Push for Faster Approvals, and Sweeping Reforms

In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlines an expansive agenda to accelerate drug approvals, lower costs, a...

medical-devices
Read More
FDA Seeking Input on Expanding Digital Health Tech in Trials

Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health technologies in cli...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
Mitapivat Moving Toward Accelerated Approval in Sickle Cell: Agios

Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell diseas...

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...

Human Drugs

View All
motusgi
Read More
October Deadline for New Adverse Event Reporting Standard

FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated int...

motusgi
Read More
Context Therapeutics’ Ovarian Cancer Drug Wins Fast Track

FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for tr...

motusgi
Read More
FDA Enforcement Discretion for Some Hemp CBD Products

FDA says it will exercise enforcement discretion and not enforce specific sections of the Federal Fo...

motusgi
Read More
Trump Plans New Tariffs on Pharmaceutical Industry

President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting...

Marketing

View All
motusgi
Read More
Modernize DTC Ads with QR Code: WLF

A Washington Legal Foundation background document suggests that Congress change direct-to-consumer d...

motusgi
Read More
Influencers’ Drug Promotions Pose Public Health Risks: JAMA

A new study published in JAMA Network Open highlights growing public health concerns over prescripti...

motusgi
Read More
Hims & Hers Super Bowl Ad Hit

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of J...

motusgi
Read More
FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer pr...

Medical Devices

View All
motusgi
Read More
FDA Expanding Real-World Evidence Use in Device Regulation

CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device ...

motusgi
Read More
FDA Denies CAD/CADt Device 510(k) Exemption Petition

FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology...

motusgi
Read More
Multiple Violations in Physitemp Instruments Inspection

FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Un...

motusgi
Read More
FDA Guide on Patient Preferences in Device Submissions

FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Ov...