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TXT FDA Listing on Device EUAs During Covid [73 Words] [ Price : $8.95]
Federal Register notice: FDA announces a periodic listing of Emergency Use Authorizations for certain medical devices related to the Covid–19 public health emergency.
10/28/2021
 
 
TXT 4 Information Collections Approved by OMB [91 Words] [ Price : $8.95]
Federal Register notice: FDA posts a list of information collections that have been approved by OMB.
10/28/2021
 
 
TXT Enzyvant Wins Priority Review Voucher [89 Words] [ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher to Enzyvant Therapeutics in response to its approval of a qualified rare pediatric disease product application.
10/28/2021
 
 
TXT HHS, Purdue Differ on Buprenorphine [2842 Words] [ Price : $8.95]
As HHS suggests increasing access to buprenorphine to treat opioid addiction, manufacturer Purdue Pharma emphasizes its addiction risks.
10/28/2021
 
 
TXT OPDP to Study Targeted Mechanism of Action in Ads [2680 Words] [ Price : $8.95]
The CDER Office of Prescription Drug Promotion says it will study how consumers and healthcare professionals react to promotional materials using the term targeted mechanism of action about a drug.
10/28/2021
 
 
TXT Millions of J&J Covid Doses in Storage: Report [2790 Words] [ Price : $8.95]
Millions of J&J Covid vaccine doses are reported to be sitting in the Emergent facility in Baltimore waiting for FDA to authorize shipment.
10/28/2021
 
 
TXT NeuroLogica AI Lung Nodule Detector Cleared [100 Words] [ Price : $8.95]
FDA clears a NeuroLogica 510(k) for its Auto Lung Nodule Detection (ALND) tool, a computer-assisted detection device for detecting pulmonary nodules.
10/28/2021
 
 
TXT Life Tech Covid Test’s EUA Revoked [283 Words] [ Price : $8.95]
Federal Register notice: FDA announces the revocation of the Emergency Use Authorization issued to Life Technologies Corporation for the TaqPath CovidD–19 MS2 Combo Kit 2.0.
10/28/2021
 
 
TXT Takeaways from FDA AI/ML Transparency Workshop [2717 Words] [ Price : $8.95]
Two Morrison Foerster attorneys list five takeaways from an FDA virtual public meeting on artificial intelligence/machine learning transparency.
10/28/2021
 
 
TXT FDA Efforts to Promote Safe Benzodiazepine Use [2964 Words] [ Price : $8.95]
CDER associate director for controlled substances Marta Sokolowska shares issues raised at an FDA/Duke-Margolis Center for Health Policy workshop on safe benzodiazepine use.
10/28/2021
 
 
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