FDA Webview
X
latest-news

FDA warns India’s Reliance Life Sciences about significant CGMP violations in its production of finished drugs.

latest-news

FDA warns Jabil Inc. about significant CGMP violations at its Pharmaceutics International unit in Cockeysville, MD.

LATEST NEWS

View All
motusgi
CGMP Violations Seen at India’s Reliance Life Sciences

FDA warns India’s Reliance Life Sciences about significant CGMP violations in its production of finished drugs.

motusgi
Pharmaceutics International CGMP Violations

FDA warns Jabil Inc. about significant CGMP violations at its Pharmaceutics International unit in Cockeysville, MD.

motusgi
2 Companies Pause Some CAR T Studies

Novartis and Bristol Myers Squibb confirm to BioSpace that they are suspending some CAR T candidate trials to evaluate adverse events that included deaths.

motusgi
FDA Backs PFAS Used in Medical Devices

FDA adds a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices, saying it has found no evidence that certain PFAS materials are harming patients.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
Antimicrobial Animal Drug Finalized Safety Guidance

FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.

medical-devices
Read More
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
Read More
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
Read More
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...

Biologics

View All
medical-devices
Read More
FDA Approves Updated Covid-19 Vaccines for Upcoming Season

FDA approves updated Covid-19 vaccines from Moderna, Pfizer-BioNTech and Novavax/Sanofi for the upcoming vaccination season.

medical-devices
Read More
FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pediatric patients.

medical-devices
Read More
Jemperli sBLA for Rectal Cancer Accepted for Priority Review

FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for certain patients with previously untreated Stage II and III loca...

medical-devices
Read More
HHS Seeks Input on Categories of Federal Vaccine Recommendations

HHS seeks input on how the federal government classifies vaccine recommendations, including whether its current system gives patients and parents enou...

FDA General

View All
medical-devices
Read More
FDA, SEC Sign MOU on Sharing Info on Medical-Product Companies

FDA and the U.S. Securities and Exchange Commission sign an MOU to strengthen cooperation and share information involving companies and products regu...

medical-devices
Read More
HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.

medical-devices
Read More
Webinar on FDA’s Bayesian Draft Guidance

FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics.

medical-devices
Read More
Commissioner Pick Faces Potentially Lengthy Senate Confirmation

Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
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...

motusgi
Read More
FDA Warns Brazilian Drug Maker Over Records Request

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

motusgi
Read More
FDA Delays Review Action on Alzheimer’s Drug

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

motusgi
Read More
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

View All
motusgi
Read More
CGMP Violations Seen at India’s Reliance Life Sciences

FDA warns India’s Reliance Life Sciences about significant CGMP violations in its production of fini...

motusgi
Read More
Pharmaceutics International CGMP Violations

FDA warns Jabil Inc. about significant CGMP violations at its Pharmaceutics International unit in Co...

motusgi
Read More
2 Companies Pause Some CAR T Studies

Novartis and Bristol Myers Squibb confirm to BioSpace that they are suspending some CAR T candidate ...

motusgi
Read More
Guidance on Pharmacokinetics in Patients with Impaired Hepatic Function

FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: ...

Marketing

View All
motusgi
Read More
FDA Hits Alar Pharmaceuticals Experimental Ketamine Promotion

FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigationa...

motusgi
Read More
FDA Promotion Crackdown Enters New Phase: Attorneys

Attorneys from Arnall Golden Gregory examine and offer advice on FDA’s intensified scrutiny of drug ...

motusgi
Read More
FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within th...

motusgi
Read More
FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respi...

Medical Devices

View All
motusgi
Read More
FDA Backs PFAS Used in Medical Devices

FDA adds a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl ...

motusgi
Read More
Two Guidances on Dental Composites and Curing Lights

FDA posts two guidance documents on dental composite resins and curing lights.

motusgi
Read More
Alert on Boston Scientific’s Angiographic Catheters

FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers rec...

motusgi
Read More
QMSR Finding Single Risk Thread: Report

MasterControl issues its 2026 life sciences regulatory readiness playbook demonstrating the signific...