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TXT Comments on OND Opportunities, Priorities [2971 Words] [ Price : $8.95]
Several stakeholders comment on an FDA reorganization plan for the Office of New Drugs intended to speed and facilitate drug development.
01/08/2020
 
 
TXT FDA Onsite Verification of Device Facility Info [2633 Words] [ Price : $8.95]
FDA asks for medical device industry cooperation with onsite verification of facility information provided to the agency.
01/08/2020
 
 
TXT Enforcement Guide on Nicotine Delivery Systems [90 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.”
01/07/2020
 
 
TXT Info Collection Extension on Animal Drug Index [96 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species — 21 CFR Part 516.”
01/07/2020
 
 
TXT Expedited Development, Approval in 60% of Novel Drugs [2648 Words] [ Price : $8.95]
A CDER report on 2019 novel drug approvals shows that 60% of the 48 drugs approved came under at least one expedited development and review method and that CDER met all PDUFA goal dates for all 48 drugs.
01/07/2020
 
 
TXT BioMarin Wants Better CDER/Sponsor Communications [2757 Words] [ Price : $8.95]
Stakeholders look for ways to improve meaningful communication between the Office of New Drugs and stakeholders involved in drug development.
01/07/2020
 
 
TXT CBER Approved Gene Therapy, 3 Vaccines in 2019 [2802 Words] [ Price : $8.95]
The FY 2019 report issued by CBER director Peter Marks touts several different types of drug and vaccine approvals.
01/07/2020
 
 
TXT IceCure Medical Cleared for Cryoablation Tech [107 Words] [ Price : $8.95]
FDA clears an IceCure Medical 510(k) for its Cryoablation Technology and its use to destroy benign and cancerous tumors by freezing them.
01/07/2020
 
 
TXT Abbott Gets Approval for HeartMate 3 Surgical Technique [200 Words] [ Price : $8.95]
FDA approves Abbott’s new alternative surgical technique for its HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery.
01/07/2020
 
 
TXT FDA Meeting on Data Strategy Modernization [5232 Words] [ Price : $8.95]
FDA schedules a 3/27 public meeting on modernization of the agency’s data strategy.
01/07/2020
 
 
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