FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA, Switzerland Recognizing Each Other's Inspections

[ Price : $8.95]

FDA and Switzerland enter into a mutual recognition agreement where each regulatory agency can rely on each others GMP inspections...

FDA, EMA Collaborate on Post-Approval Changes

[ Price : $8.95]

Under a new pilot program, FDA and the European Medicines Agency complete the first collaborative assessment of a proposed post-ap...

FDA Not Yet Implementing OTC Drug Reforms: GAO

[ Price : $8.95]

A Government Accountability Office review of FDAs over-the-counter drug monograph program performance finds that the agency has no...

Info Collection on Device Improvement Program

[ Price : $8.95]

Federal Register notice: FDA sends to OMB a new medical device-related information collection entitled Voluntary Improvement Progr...

Guide on Devices Opioid Use Disorder

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Clinical Considerations for Studies of Devices Intended to ...

UltraSight Ultrasound Guidance Software Cleared

[ Price : $8.95]

FDA clears an UltraSight 510(k) for its artificial intelligence-powered ultrasound guidance technology.

Contact Lens Care Product Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consume...

Guide on Drug Quality Consensus Standards

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled CDERs Program for the Recognition of Voluntary Consensus St...

Opioid Disorder Innovative Devices

[ Price : $8.95]

FDA issues a draft guidance to help sponsors design pivotal clinical trials for innovative medical devices to treat opioid use dis...

Compliance Woes at Wegovy Syringe Plant

[ Price : $8.95]

Reuters says FDA documents show sterility issues at the Catalent facility in Brussels, Belgium, that fills Wegovy syringes for Nov...