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TXT Gene Editing Stakeholder Comments [275 Words] [ Price : $8.95]
Six stakeholders provide comments to FDA on the agency’s docket on human gene therapy products incorporating human genome editing.
06/16/2022
 
 
TXT Researchers Confirm Increasing AI/ML Role in Drug Development [218 Words] [ Price : $8.95]
CDER researchers describe the increasing use of artificial intelligence/machine learning in drug development regulatory submissions.
06/16/2022
 
 
TXT CDER Caught Up on Domestic Pre-approval Inspections: Cavazzoni [910 Words] [ Price : $8.95]
CDER director Patrizia Cavazzoni puts a positive spin on drug inspections, user fee goals, and enforcement and compliance activities, notwithstanding some performance setbacks this fiscal year.
06/16/2022
 
 
TXT FDA Approves Rhythm Pharma sNDA for Imcivree [210 Words] [ Price : $8.95]
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.
06/16/2022
 
 
TXT Guide on Regenerative Medicines Consensus Standards [78 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”
06/16/2022
 
 
TXT Info Collection Revision on CLIA Waivers [125 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision entitled “Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988.”
06/16/2022
 
 
TXT Advisors to Consider Acadia’s Nuplazid for Alzheimer’s Psychosis [274 Words] [ Price : $8.95]
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.
06/15/2022
 
 
TXT Alston & Bird Attorneys Review PDUFA 7 Provisions [464 Words] [ Price : $8.95]
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.
06/15/2022
 
 
TXT Pfizer Stops Enrolling Standard Risk Patients in Paxlovid Trial [205 Words] [ Price : $8.95]
Pfizer says it will stop enrolling standard risk patients in the EPIC-SR trial of its anti-Covid therapy Paxlovid and submit data to FDA in an NDA.
06/15/2022
 
 
TXT Senate HELP Committee Passes FDA User Fee Bill [629 Words] [ Price : $8.95]
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.
06/15/2022
 
 
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