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The Trump Administration considers White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner.

latest-news

Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attrition as signs of an agency staffing turnaround and improvement in morale.

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Administration Weighs White House Aide for FDA Top Post

The Trump Administration considers White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner.

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FDA ‘Making Good Progress’ Hiring New Staff: Zeta

Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attrition as signs of an agency staffing turnaround and improvement in morale.

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FDA FY 2027 Appropriation Report Analyzed

Eight Hyman, Phelps & McNamara attorneys analyze a House Appropriations Committee report that explains its rationale and expectations for the FY 2027 FDA funding appropriation.

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JAMA Publishes Previously Blocked Covid-19 Vaccine Study

JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers for Disease Control and Prevention journal due to alleged political interference.

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Animal Drugs

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medical-devices
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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
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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
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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...

medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

Biologics

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medical-devices
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JAMA Publishes Previously Blocked Covid-19 Vaccine Study

JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers for Disease Control an...

medical-devices
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Beam Gets OK to Begin Clinical Testing of PKU Gene-Editing Therapy

FDA approves a Beam Therapeutics IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing treatment for pheny...

medical-devices
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Expand Some Islet Cell Transplantation Access: Senators

Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type 1 diabetes patients...

medical-devices
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Senator Seeks FDA Records on Covid Vaccine Safety Review

Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from HHS, FDA and CDC re...

FDA General

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medical-devices
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Administration Weighs White House Aide for FDA Top Post

The Trump Administration considers White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner.

medical-devices
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FDA ‘Making Good Progress’ Hiring New Staff: Zeta

Speaking at a BIO International Convention FDA Town Hall, several agency executives cite increases in hiring and decreases in attrition as signs of an...

medical-devices
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Gottlieb Praises Clinical Trial Initiative; Calls for FDA Career Leadership

Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the p...

medical-devices
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Ex-FDA Head Gottlieb Warns on Politicization Threatening Scientific Credibility

Former FDA commissioner Scott Gottlieb urges federal health officials to restore scientific leadership at the agency's medical product centers.

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Federal Register

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FDA Warns Brazilian Drug Maker Over Records Request

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

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FDA Delays Review Action on Alzheimer’s Drug

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

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

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PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

Human Drugs

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FDA Details Standardized Approach to Drug Safety Signal Detection

A new CDER Office of New Drugs webinar discusses the development and use of OND Custom Medical Que...

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JAMA Revisits FDA's Controversial OK of Depression Drug Gepirone

A new analysis published in JAMA Psychiatry raises fresh questions about how FDA evaluates drug effi...

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FTC Weighs in Against J&J in Stelara Monopoly Case

The Federal Trade Commission files an amicus brief supporting plaintiffs in an antitrust lawsuit acc...

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Drug Trial Demographic Info Reported

FDA publishes a report summarizing demographic information from pivotal trials supporting 46 novel n...

Marketing

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FDA Cites QOL Medical for Misleading Promotion of Sucraid

FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease ...

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FDA Drug Ad Crackdown Leads to More Spending on TV/Streaming Ads: Report

An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in p...

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DTC Crackdown Unfazed at Post-Makary FDA: Expert

DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary i...

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Brukinsa TV Ad ‘False or Misleading’: OPDP

A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine T...

Medical Devices

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Require IDE for Vena’s MicroAngioscope: Petition

Harmed Americans for Reform in Medical Device Safety petitions FDA to require an IDE for the Vena Mi...

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FDA Issues Early Alert on Abiomed Impella Introducer Kits

FDA issues an early alert warning healthcare providers about a potentially high-risk device issu...

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FDA Nixes Enforcement Action Against Whoop's Blood Pressure Feature

FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory positi...

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Data from First 100 QMSR Inspections Analyzed

Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 ...