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Pushing randomized clinical trials, FDA issues a draft guidance entitled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.”

latest-news

FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed to be marketed under the agency’s enforcement discretion policy.

LATEST NEWS

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Accelerated Approval Guide Pushes Randomized Trials

Pushing randomized clinical trials, FDA issues a draft guidance entitled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.”

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Two Final Guides on Covid-19 Device Transition

FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed to be marketed under the agency’s enforcement discretion policy.

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Dose Optimization Info for Combo Drugs Needed: PhRMA

Pharmaceutical Research and Manufacturers of America says a recent FDA draft guidance on oncologic drug development provides limited information on how to optimize the dosage for oncology combination products.

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FDA Keeping Close Eye on Social Media Promotion

CDER's Office of Prescription Drug Promotion (OPDP) says it is monitoring very closely the increasing use of social media platforms that promote prescription drugs.

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Animal Drugs

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medical-devices
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Guide on Developing Dog Heartworm Drugs

The agency is seeking public comment on the guidance for 60 days.

medical-devices
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FDA Approves Zycosan for Horses with Osteoarthritis

FDA approves the first injectable pentosan product for use in horses with osteoarthritis.

medical-devices
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Updated CVM Guide on Antimicrobial Resistance Risks

FDA issues a draft update to guidance for industry #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological...

medical-devices
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CVM Sees 1% Decrease in Food Animal Antimicrobial Use

CVM posts its 2021 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals that shows antimicrobial drug sales for such...

Biologics

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medical-devices
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Cell/Gene Therapy Post-approval Data Meeting

CBER's Office of Therapeutic Products plans a 4/27 public listening meeting to obtain feedback on methods and approaches for capturing post-approval s...

medical-devices
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Workforce, Education for Regenerative Medicine

The Government Accountability Office reports on regenerative medicine and advanced therapies workforce and education/training needs.

medical-devices
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Biological Product Deviation Reports Up: CBER

The CBER FY 2022 biological product deviation reporting annual summary says there was a 3% increase in reports submitted over FY 2021.

medical-devices
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Regeneron’s Evkeeza Expanded Use in Young Children

FDA approves an expanded indication for Regeneron Pharmaceuticals’ Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to tr...

FDA General

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medical-devices
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OSTP Goals for Biotechnology and Biomanufacturing

A new White House Office of Science and Technology Policy (OSTP) report lists 10 bold goals for the U.S. biotechnology and biomanufacturing.

medical-devices
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Senate Appropriators Announce 4/19 FDA Budget Hearing

The Senate Appropriations Committee announces a 4/19 subcommittee hearing to review FDA’s fiscal year 2024 budget request.

medical-devices
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FDA Webview Reaches Out for Your Guidance

Still evolving under the same leadership, Dickinson’s FDA Webview asks subscribers to help guide our further development and improve service.

medical-devices
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FDA Bioresearch Inspection Findings Out

FDA annual inspection metrics from its Bioresearch Monitoring program show that the most common clinical investigator inspectional observations involv...

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Federal Register

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CDER/CBER Digital Health Framework

Federal Register notice: FDA releases CDER/CBER’s “Framework for the Use of Digital Health Technolog...

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Comments Sought on REMS Modification Requests

Federal Register notice: FDA establishes a docket to solicit comments on factors that should be cons...

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Shionogi’s Mulpleta Regulatory Review Period

Federal Register notice: FDA determines for patent extension purposes the regulatory review period f...

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Regulatory Review Period for Galafold

Federal Register notice: FDA determines for patent extension purposes the regulatory review period f...

Human Drugs

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Accelerated Approval Guide Pushes Randomized Trials

Pushing randomized clinical trials, FDA issues a draft guidance entitled “Clinical Trial Considerati...

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Read More
Dose Optimization Info for Combo Drugs Needed: PhRMA

Pharmaceutical Research and Manufacturers of America says a recent FDA draft guidance on oncologic d...

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Incyte Complete Response on Once-daily Jakafi

FDA issues Incyte a complete response letter for Jakafi (ruxolitinib) extended-release tablets, a JA...

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Panel Backs Accelerated OK Consideration of Biogen's ALS Drug

An FDA advisory committee votes 9 to 0 that Biogen’s amyotrophic lateral sclerosis drug tofersen sho...

Marketing

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Regulators Need to Keep Up with ‘Patient Influencers’: Study

A new University of Colorado Boulder study points to the need for FDA to work harder to follow and c...

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Drug Promotion Research Landscape Analyzed

FDA and RTI International researchers review empirical studies of prescription drug promotion in the...

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Lower Added Benefit Associated with Higher DTC Spend

Johns Hopkins University researchers say spending on direct-to-consumer ads in 2020 was associated w...

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GoodRx Paying $1.5 Million for Consumer Data Breach

The Federal Trade Commission says GoodRx will pay a $1.5 million civil penalty for failing to tell c...

Medical Devices

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Two Final Guides on Covid-19 Device Transition

FDA issues two final guidances on transition plans for Covid-19-related medical devices that were gr...

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New CDRH Web Page on Diagnostic Data Program

CDRH launches a new Web page to discuss “mission-critical priorities of data and technology innovati...

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Getinge PMA Approved for Iliac Artery Stent

FDA approves a Getinge PMA for its iCast covered stent system for treating patients with iliac arter...

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Xtrava Covid Test Less Effective with Some Variants: FDA

FDA adds the Xtrava Health SPERA Covid-19 test to the list of tests expected to have a reduced perfo...