HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 71,148 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
<< Prev  11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Next >>
 
TXT CDER Web-Based Meeting MAPP [2612 Words] [ Price : $8.95]
A CDER Manual of Policies and Procedures outlines policies and responsibilities of meeting participants when they are working remotely and using Web-based meeting functions.
12/09/2021
 
 
TXT Clinical Hold Lifted on Aprea Therapeutics [138 Words] [ Price : $8.95]
FDA lifts a clinical hold against an Aprea Therapeutics clinical trial evaluating the combination of its lead compound, eprenetapopt, with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies.
12/09/2021
 
 
TXT EUA Expanded for Pfizer Covid Vaccine [150 Words] [ Price : $8.95]
FDA grants Pfizer and BioNTech an expanded emergency use authorization for their Covid-19 vaccine booster to include individuals 16 years of age and older.
12/09/2021
 
 
TXT Synaptent Marketing Unapproved New Drugs: FDA [2694 Words] [ Price : $8.95]
FDA warns Chicago-based Synaptent it is marketing unapproved and misbranded new drugs as dietary supplements.
12/08/2021
 
 
TXT 8 Observations in Dr. Reddy’s FDA-483 [2774 Words] [ Price : $8.95]
FDA releases the FDA-483 with eight observations issued following an inspection at a Dr. Reddy’s sterile drug manufacturing facility in India.
12/08/2021
 
 
TXT Woodcock’s Priorities for FDA Under Califf [2874 Words] [ Price : $8.95]
Departing FDA interim commissioner Janet Woodcock identifies some priorities she hopes incoming commissioner Robert Califf will continue pursuing.
12/08/2021
 
 
TXT Antisense Oligonucleotide IND Clinical Recommendations [85 Words] [ Price : $8.95]
Federal Register notice: FDA draft guidance provides IND clinical recommendations for Individualized Antisense Oligonucleotide Drug Products.
12/08/2021
 
 
TXT IND Guide for Antisense Oligonucleotide Products [112 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.
12/08/2021
 
 
TXT Pfizer to Submit Anti-Covid Paxlovid Data to FDA [2635 Words] [ Price : $8.95]
Pfizer says it will submit full Paxlovid anti-Covid trial data to FDA in a few days.
12/08/2021
 
 
TXT Clinical Outcome Assessment Compendium Updated [2778 Words] [ Price : $8.95]
FDA publishes an updated Clinical Outcome Assessment Compendium.
12/08/2021
 
 
<< Prev  11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30  Next >>
 

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