HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 72,321 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
<< Prev  15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 Next >>
 
TXT More Product-specific Bioequivalence Guides [57 Words] [ Price : $8.95]
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances.
05/20/2022
 
 
TXT Guide on New Dietary Ingredient Notifications [120 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.”
05/20/2022
 
 
TXT Device Cybersecurity Clarifications in FDA Webinar [157 Words] [ Price : $8.95]
FDA announces a 6/14 Webinar to share information and answer questions about its recent draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”
05/20/2022
 
 
TXT FDA Approves Dupixent for Eosinophilic Esophagitis [271 Words] [ Price : $8.95]
FDA approves Regeneron’s Dupixent (dupilumab) for treating eosinophilic esophagitis in adults and pediatric patients 12 years and older.
05/20/2022
 
 
TXT House Commerce Republicans Probe China Trials [298 Words] [ Price : $8.95]
House Energy and Commerce Committee Republican leaders ask FDA commissioner Robert Califf to answer questions about a growing trend for clinical trials to rely solely on enrollment of patients from a single country, particularly China, and the history of fabricated data in clinical trials conducted in China.
05/20/2022
 
 
TXT Dietary Supplement NDI Enforcement Discretion [2844 Words] [ Price : $8.95]
FDA publishes a draft guidance on possible enforcement discretion so dietary supplement companies can correct past failures to submit required new dietary ingredient premarket notifications.
05/19/2022
 
 
TXT FDA Moving Toward Emerging Technology Regs: Kopcha [2750 Words] [ Price : $8.95]
CDER Office of Pharmaceutical Quality director Michael Kopcha says the agency is working on regulations to help companies become more comfortable with advanced manufacturing technologies.
05/19/2022
 
 
TXT CDRH Device Sterility Master File Pilot [340 Words] [ Price : $8.95]
CDRH announces a new “510(k) Sterility Change Master File Pilot Program” that is intended to give interested companies that terminally sterilize single-use devices (sterilization providers) using certain sterilization methods a pathway to submit a master file for the Center’s review.
05/19/2022
 
 
TXT Drug Shortage Risk Management Guidance [2670 Words] [ Price : $8.95]
FDA publishes a draft guidance to help develop, maintain, and implement risk management plans to assist in preventing human drug shortages.
05/19/2022
 
 
TXT FDA Enterprise Modernization Plan Explained [2825 Words] [ Price : $8.95]
FDA principal deputy commissioner Janet Woodcock explains the components of the agency’s new Enterprise Modernization Action Plan.
05/19/2022
 
 
<< Prev  15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34  Next >>
 

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com