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TXT New CDRH Tool for ’Scope Reprocessing Assurance [543 Words] [ Price : $8.95]
CDRH scientists and engineers develop a new tool to help hospitals determine how clean an endoscope is after it has been reprocessed.
01/09/2020
 
 
TXT Info Collection on Administrative Practice/Procedures [79 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision for “General Administrative Practice and Procedures.”
01/09/2020
 
 
TXT Much of Higher Drug Spending Not Going to Companies: PhRMA [2706 Words] [ Price : $8.95]
A PhRMA-funded study says drug companies are not retaining much of the increased drug spending in the U.S.
01/09/2020
 
 
TXT Penumbra Expanded Indication for Aspiration Device [86 Words] [ Price : $8.95]
FDA clears a Penumbra 510(k) for an expanded indication for its Indigo Aspiration System — treating pulmonary embolisms.
01/09/2020
 
 
TXT Public Meeting on Modernizing FDA Data Strategy [71 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 3/27 public meeting entitled “Modernizing FDA’s Data Strategy.”
01/08/2020
 
 
TXT Comments Extended on Certificates of Confidentiality Guide [135 Words] [ Price : $8.95]
Federal Register notice: FDA extends until 1/24 the comment period for a draft guidance entitled “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.”
01/08/2020
 
 
TXT FDA Focus Group Info Collection Extension [136 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension on “Focus Groups as Used by the Food and Drug Administration (All FDA-Regulated Products).”
01/08/2020
 
 
TXT Comments Extended on Homeopathic Drug Guide [81 Words] [ Price : $8.95]
Federal Register notice: FDA extends until 3/23 the comment period on a revised draft guidance entitled “Drug Products Labeled as Homeopathic.”
01/08/2020
 
 
TXT Blueprint Rolling NDA for Lung Cancer Drug [160 Words] [ Price : $8.95]
Blueprint Medicines begins a rolling NDA submission for pralsetinib after reporting top-line data from a pralsetinib study in patients with RET fusion-positive non-small cell lung cancer.
01/08/2020
 
 
TXT Quality by Design Advantages Explained [2683 Words] [ Price : $8.95]
Recipharm staffers discuss the advantages of a quality by design approach to drug manufacturing.
01/08/2020
 
 
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