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Welcome to FDAweb Pay Per View Search our 70,821 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Next >>   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     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     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     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     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the agency determines whether a consumer product is “intended” for drug or medical device use. 10/26/2021     Expand Draft Guidance on BE Studies in ANDAs: AAM [2625 Words] [ Price : $8.95] The Association for Accessible Medicines recommends broadening an FDA draft guidance on some ANDA bioequivalence studies. 10/26/2021     LDT Oversight Legislation Needed: Pew Research [2767 Words] [ Price : $8.95] The Pew Charitable Trusts say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     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     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     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     << Prev  8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27  Next >>

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