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Welcome to FDAweb Pay Per View Search our 72,320 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   Outsourcing Facility Producing Illegal Drugs: FDA [391 Words] [ Price : $8.95] FDA warns Deerfield Beach, FL-based Hybrid Pharma about multiple violations in its work as an outsourcing facility. 06/14/2022     Alnylam Pharma Amyloidosis Therapy Approved [148 Words] [ Price : $8.95] FDA approves an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection once every three months for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis. 06/14/2022     FDA Draft Trial Diversity Guidance Outlined [288 Words] [ Price : $8.95] Troutman Pepper attorneys discuss a new FDA draft guidance giving sponsors information on presenting diversity plans to enroll under-represented populations in drug and medical device trials. 06/14/2022     FDA Makena Advisory Committee Set for Mid-October [91 Words] [ Price : $8.95] The presiding officer for a hearing on a CDER proposal to withdraw approval for Covis’ Makena says the hearing will be held 10/17-10/19. 06/14/2022     Do More to Promote Generic Competition: White Paper [322 Words] [ Price : $8.95] A Brookings Institution white paper lists six policy changes FDA could make to enhance generic drug competition. 06/14/2022     Califf on Tweaking Accelerated Approvals, No Big Revamp [949 Words] [ Price : $8.95] FDA commissioner Robert Califf says a total revamp of the drug accelerated approval program is not needed to answer criticism following a number of drug indications being withdrawn because companies were unable to generate confirmatory data. 06/14/2022     ‘Whole-of-Governments’ Approach to Illicit Medical Products [235 Words] [ Price : $8.95] FDA says it is working with the Organization of Economic Cooperation and Development on a “whole-of-governments” approach to fighting illicit medical products. 06/14/2022     FDA to Study Breast Implant Risk Perception [168 Words] [ Price : $8.95] FDA says it is funding a study of patient perceptions of the risk of a specific cancer associated with textured breast implants. 06/14/2022     Panel Backs Moderna Covid Vaccine in Children [209 Words] [ Price : $8.95] An FDA advisory committee votes unanimously (22 to 0) to recommend the agency grant Moderna an emergency use authorization for its Covid-19 vaccine in children aged six months to 17 years. 06/14/2022     ICH Draft Quality Risk Management Guidance [190 Words] [ Price : $8.95] FDA publishes a draft International Council for Harmonization guidance on quality risk management with no new regulatory expectations. 06/14/2022     << Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

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