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TXT 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
 
 
TXT 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
 
 
TXT 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Troutman Pepper attorneys discuss a new FDA draft guidance giving sponsors information on presenting diversity plans to enroll under-represented populations in drug and medical device trials.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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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of the drug accelerated approval program is not needed to answer criticism following a number of drug indications being withdrawn because companies were unable to generate confirmatory data.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
 
 
TXT ‘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
 
 
TXT 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
 
 
TXT 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
 
 
TXT 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
 
 
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