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TXT Novartis Phase 3 Lung Cancer Trial Doesn’t Hit Endpoints [2701 Words] [ Price : $8.95]
Novartis says further evaluation of its lung cancer treatment canakinumab is warranted even though a Phase 3 trial did not meet its primary endpoints.
10/26/2021
 
 
TXT Alternative Tools Let FDA Slash Preapproval Inspections by 55% [1008 Words] [ Price : $8.95]
CDER Office of Pharmaceutical Manufacturing Assessment director Stelios C. Tsinontides says FDA’s need to conduct preapproval inspections was reduced by 55% during the Covid-19 pandemic by the agency’s use of alternative inspection tools.
10/26/2021
 
 
TXT Two Biological Products Reporting Exemption [155 Words] [ Price : $8.95]
Federal Register proposed order: FDA proposes to exempt certain blood and blood components for transfusion and cell and gene therapy products from annual reporting.
10/26/2021
 
 
TXT WLF Asks Court to Uphold Labeling Preemption [2720 Words] [ Price : $8.95]
Washington Legal Foundation says the 9th Circuit Court of Appeals should uphold a lower court multi-district litigation decision that federal law preempts state law claims in a Victoza labeling case.
10/26/2021
 
 
TXT New Final Rule Expands ‘Intended Use’ Definition: Attorneys [2802 Words] [ Price : $8.95]
Sidley attorneys say a new FDA final rule expands the ways the agency determines whether a consumer product is “intended” for drug or medical device use.
10/26/2021
 
 
TXT Expand Draft Guidance on BE Studies in ANDAs: AAM [2625 Words] [ Price : $8.95]
The Association for Accessible Medicines recommends broadening an FDA draft guidance on some ANDA bioequivalence studies.
10/26/2021
 
 
TXT LDT Oversight Legislation Needed: Pew Research [2767 Words] [ Price : $8.95]
The Pew Charitable Trusts say Congress should give FDA authority to regulate some higher-risk laboratory-developed tests.
10/26/2021
 
 
TXT Panel Backs Pfizer Vaccine in Younger Kids [204 Words] [ Price : $8.95]
FDA’s Vaccines and Related Biological Products Advisory Committee votes to recommend the agency authorize the use of Pfizer’s Covid-19 lower-dose vaccine in children ages 5 to 11 years.
10/26/2021
 
 
TXT OMB Info Collection on Drug Registration [145 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection revision entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution — 21 CFR Part 207.”
10/26/2021
 
 
TXT Eyenovia ‘Complete Response’ Related to Genus Decision [303 Words] [ Price : $8.95]
Eyenovia receives a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupil dilation, because the agency had reclassified the drug as a drug-device combination product pursuant to a recent court decision.
10/25/2021
 
 
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