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Abbott MRI Labeling OK’d for Spinal Stimulator 05/11/2023

Study Data Technical Conformance Guide 05/11/2023

Stakeholder Ideas on FDA Electronic System Draft 05/11/2023

FDA Wants Updated Labeling on Some Stimulants 05/11/2023

Panel to Discuss Pediatric Oncology Dose Optimization 05/10/2023

CDER Publishes AI/ML Discussion Paper 05/10/2023

Reviewers Question Sarepta DMD Drug 05/10/2023

Bill Would Force Drug Research Cost Disclosure 05/10/2023

FDA Clears Renuvion Handpiece 05/10/2023

Panel Unanimously Backs OTC Contraceptive Pill 05/10/2023

Glycol Testing Guidance 05/09/2023

CGMP Violations in Premier Nutra Pharma Inspection 05/09/2023

Court Backs FDA in Somatuline Depot Case 05/09/2023

FDA Clears Cumulus EEG Headset 05/09/2023

AI/ML Predetermined Change Control Plan Guidance 05/09/2023

FDA Reviewers Question ARS-1 Development Program 05/09/2023

Clinical Hold Lifted on Diarrhea Trials 05/08/2023

Singlera ‘Breakthrough’ on Pancreatic Cancer Assay 05/08/2023

2-Day Workshop on Generic Research Iniitiatives 05/08/2023

Samsung Irregular Heart Monitor on Watch Cleared 05/08/2023

De Novo Marketing of 2 Covid Serology Tests 05/08/2023

Califf Warns of Regulation of Large Language Models 05/08/2023

FDA Releases Sun Non-compliance Letter 05/08/2023

New Web Page on Antimicrobial Susceptibility Tests 05/05/2023

Fibrogen Misses Endpoint in Roxadustat Anemia Trial 05/05/2023

FDA Issues Ajinomoto Bio-Pharma 3-item 483 05/05/2023

PhRMA, Others Petition Against Drug Importation 05/05/2023

Actual Use Study Flagged in OTC Birth Control NDA 05/05/2023

Levitra Not Withdrawn Due to Safety/Efficacy 05/04/2023

Guide on Decentralized Clinical Trials 05/04/2023

Reject Rexulti Alzheimer’s sNDA: Public Citizen 05/04/2023

Name NIH in Drug Patent Applications: GAO 05/04/2023

Xortx to Pursue Accelerated Approval for Xorlo 05/04/2023

Device Regulatory Science Tool Catalog Update 05/04/2023

Califf Recommends FDA Reforms for Pandemic Bill 05/04/2023

FDA Novo Nordisk Concizumab Complete Response Letter 05/04/2023

Members of Congress Seek Mifepristone Reversal 05/03/2023

Rentschler Biopharma Germany Site 483 05/03/2023

Lilly Eyes Fast OK for Donanemab in Alzheimer’s 05/03/2023

GSK Wins Approval for 1st RSV Vaccine 05/03/2023

ICH Quality Risk Management Guidance Published 05/03/2023

Innovative Manufacturing Approaches Notice Corrected 05/03/2023

PDUFA User Fee Assessment Guidance 05/03/2023

Reps. Question FDA Pace for New Covid Therapeutics 05/03/2023

Trade Groups Comment on Externally Controlled Trials 05/03/2023

Smart Heart Toilet Seat Cleared by FDA 05/03/2023

Accelerated Approval Withdrawals Likely to Increase: Attorneys 05/02/2023

CGMP Violations in Voyant Beauty Inspection 05/02/2023

Decentralized Clinical Trial Recommendations 05/02/2023

DirectSync Gets ‘Breakthrough’ on Spinal Fusion Device 05/02/2023

Vanda Says FDA Disclosed Trade Secrets to Competitors 05/02/2023

FDA Finishes Posting OTC Drug Deemed Final Orders 05/02/2023

FDA Partial Hold on Sun JAK Inhibitor Trial 05/02/2023

Astellas/Pfizer Mulling sNDA for Xtandi 05/01/2023

Bipartisan Bill on Preventing Drug Shortages 05/01/2023

Complete Response on Hypoparathyroidism NDA 05/01/2023

Princeton BioMeditech OTC Covid Test Authorized 05/01/2023

Lilly Issued 483 on Aseptic Operations 05/01/2023

Medtronic Next-Gen Micra Pacemakers Approved 05/01/2023

Guide on Smoking Cessation Products 04/28/2023

Comments on Data/Tech Strategic Plan 04/28/2023

DTC Research to Examine Treatment Tradeoffs 04/28/2023

Petition Seeks Removal of Bamboo’s NarxCare Software 04/28/2023

Gene Therapy Guide on NonClinical Biodistribution 04/28/2023

Teva Recalls Fentanyl Lots Over Product Insert 04/28/2023

FDA Approves Otsuka/Lundbeck Schizophrenia Drug 04/28/2023

ViiV Dovato Ad Claims Challenged 04/27/2023

Drug Supply Chain Independence Bill 04/27/2023

Ultromics Gets Breakthrough Status for AI Device 04/27/2023

FDA Approves Oral Fecal Microbiota Capsules 04/27/2023

Prevent Makena Compounding: Public Citizen 04/27/2023

Gillibrand Bill to Speed FDA Approval of Some Drugs 04/27/2023

Quality Management Maturity Dividing Industry: PDA 04/27/2023

FDA Planning TV Ad Endorser Research 04/27/2023

Lilly Planning Tirzepatide Submission Soon 04/27/2023

FDA Lifts Warning Letter Against Medtronic 04/26/2023

CVM Electronic Submission Registration 04/26/2023

DefenCath NDA to be Resubmitted by Mid-May 04/26/2023

Nonrandom Data Can Emulate Random Trials: Study 04/26/2023

Iptacopan FDA Submission Coming Soon: Novartis 04/26/2023

Alvotech FDA-483 Released 04/26/2023

Bankrupt Akorn Recalls All Products 04/26/2023

Vertex Gains Expanded Use for Cystic Fibrosis Drug 04/26/2023

Advisors Asked About Olaparib sNDA Population 04/26/2023

CGMP Violations at Egypt’s Pharmaplast 04/25/2023

Florida Files 2nd Drug Import Suit Against FDA 04/25/2023

QS, MDR, Other Violations in Medivance Inspection 04/25/2023

Medolife Illegally Selling Unapproved New Drugs: FDA 04/25/2023

Streamlined Cancer Trials Can Cause ‘Discomfort’: Singh 04/25/2023

Biogen Accelerated Approval for ALS Drug 04/25/2023

Senate Bipartisan Agreement on FDA Reform Bills 04/25/2023

FDA Sends ‘Non-Compliance’ Letter to Sun Pharma 04/25/2023

Medtronic’s MiniMed 780G Gets FDA Approval 04/24/2023

Generic Group Questions Guide on Guidance Meetings 04/24/2023

Foghorn Therapeutics Hit with Partial Clinical Hold 04/24/2023

Supreme Court Gives FDA Temporary Victory 04/24/2023

OPDP Plans Survey on DTC Quantitative Claims 04/24/2023

Avanos Medical Recalls Respiratory Suction Device 04/21/2023

FDA Extends Review of Daiichi Leukemia NDA 04/21/2023

CDER Denies Bausch Petition on Duobrii ANDAs 04/21/2023

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