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TXT Paxlovid Widely Available in Pharmacies: Farley [2738 Words] [ Price : $8.95]
CDER Office of Infectious Diseases director John Farley answers healthcare provider questions about using Pfizer’s Paxlovid on authorized Covid-19 patients.
05/04/2022
 
 
TXT FDA OKs Marketing of New Alzheimer’s Diagnostic [2617 Words] [ Price : $8.95]
FDA permits marketing of a Fujirebio in vitro diagnostic test for Alzheimer’s disease.
05/04/2022
 
 
TXT Additional FDA ‘Native Advertising’ Enforcement Likely: Attorney [2829 Words] [ Price : $8.95]
Attorney Dara Levy predicts increased FDA enforcement involving so-called native advertising and other new promotional trends.
05/04/2022
 
 
TXT ICH Model-Informed Drug Development Roadmap [2585 Words] [ Price : $8.95]
The International Council on Harmonization publishes its Model-Informed Drug Development Discussion Group roadmap for future guidelines.
05/04/2022
 
 
TXT User Fee Bill Looks to Improve Accelerated Approval, Inspections [655 Words] [ Price : $8.95]
The House Energy and Commerce Committee releases a “comprehensive legislative package” to reauthorize FDA user fee agreements and enhance accelerated approvals and inspections conducted by the agency, among other improvements.
05/04/2022
 
 
TXT Revised Guide on PMA/HDE Supplements During Covid [325 Words] [ Price : $8.95]
FDA posts a revised final guidance entitled Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.
05/04/2022
 
 
TXT Senators Want Opioid Label Changes [2745 Words] [ Price : $8.95]
Sens. Hassan and Braun call on FDA commissioner Robert Califf to quickly lead a revision of opioid drug labeling.
05/03/2022
 
 
TXT FDA Lifts Hold on Pfizer Hemophilia A Gene Therapy [258 Words] [ Price : $8.95]
FDA removes a clinical hold on Pfizer’s giroctocogene fitelparvovec (Hemophilia A gene therapy); the company plans to resume dosing in its AFFINE trial in the third quarter.
05/03/2022
 
 
TXT FDA Proposes 2nd Section 518(b) Order for Philips [2744 Words] [ Price : $8.95]
FDA proposes issuing a second Section 518(b) order against Philips Respironics, this time to require the company to submit a plan to repair, replace, or refund recalled air pressure devices.
05/03/2022
 
 
TXT Confusion Over RWD and RWE: Perspective [2730 Words] [ Price : $8.95]
Two CDER executives discuss misconceptions that remain about the meaning and use of real-world data and real-world evidence.
05/03/2022
 
 
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