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Gene Editing Stakeholder Comments
[275 Words]
[ Price : $8.95]
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| Six stakeholders provide comments to FDA on the agency’s docket on human gene therapy products incorporating human genome editing. |
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06/16/2022
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FDA Approves Rhythm Pharma sNDA for Imcivree
[210 Words]
[ Price : $8.95]
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| FDA approves a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) injection, indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl Syndrome. |
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06/16/2022
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Info Collection Revision on CLIA Waivers
[125 Words]
[ Price : $8.95]
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| Federal Register notice: FDA seeks comments on an information collection revision entitled “Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988.” |
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06/16/2022
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Advisors to Consider Acadia’s Nuplazid for Alzheimer’s Psychosis
[274 Words]
[ Price : $8.95]
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| FDA says its Psychopharmacologic Drugs Advisory Committee will consider whether data from Acadia Pharmaceutical trials support an indication for the company’s Nuplazid to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. |
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06/15/2022
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Alston & Bird Attorneys Review PDUFA 7 Provisions
[464 Words]
[ Price : $8.95]
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| Four Alston & Bird attorneys describe some of the major items in the PDUFA 7 reauthorization legislation that has bipartisan support in both the House and Senate. |
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06/15/2022
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Senate HELP Committee Passes FDA User Fee Bill
[629 Words]
[ Price : $8.95]
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| The Senate Health, Education, Labor and Pensions Committee passes the FDA Safety and Landmark Advancements (FDASLA) Act, which reauthorizes the agency’s prescription drug, generic drug, biosimilar, and medical device user fee agreements for another five years. |
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06/15/2022
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