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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

Novartis Gets Another Facility OK’d for Pluvicto 04/21/2023

DTC Research Raises Concern on Endpoints in Cancer Ads 04/21/2023

10 Observations in Lupin FDA-483 04/20/2023

Sarepta Comments on Golodirsen PSG 04/20/2023

GE Healthcare’s Carescape Patient Monitor Cleared 04/20/2023

FDA Describes New QSAR Model 04/20/2023

FDA Failed to Collect $45 bil. Drug Trial Fines: Students 04/20/2023

Califf Testifies on Accelerated Approvals 04/20/2023

BelGene Gastric Cancer Drug Trial Hits Primary Endpoint 04/20/2023

CGMP Violations at Zermat International 04/19/2023

Fresenius Kabi Recalls Ivenix Infusion Device 04/19/2023

North American Diagnostics Illegal Covid Tests 04/19/2023

Radiation Syndrome Drug Development Guidance 04/19/2023

NCI Sees Revumenib Promise for Some Leukemias 04/19/2023

FDA Cautions Compounders on Bulk Sources 04/19/2023

FDA Drug Inspections Slow to Recover: Analysis 04/19/2023

Guidance Shows Importance of Sponsor Oversight: Attorneys 04/19/2023

Generic Mifepristone Maker Sues FDA 04/19/2023

High Court Adds 2 Days to Mifepristone Stay 04/19/2023

EMA/FDA Bioequivalence Info Sharing Pact Adds Ireland 04/19/2023

FDA OKs 2nd Covid Booster for Some People 04/18/2023

Lessons Learned from Rare Disease Trials During Covid 04/18/2023

OND Expands Regulatory Science Research 04/18/2023

Intarcia Raises NDA Advisory Committee Issues 04/18/2023

House Oversight Panel Puts Heat on FDA Over CBD 04/18/2023

Research Describes Drug Ad Data Display 04/18/2023

Royal Chemical Inspection Finds CGMP Violations 04/18/2023

Multiple Abbott i-STAT Test Violations 04/18/2023

Workshop on Rare Disease Endoints 04/17/2023

Panel Backs Rexulti for Alzheimer’s Agitation 04/17/2023

FDA Clears Reader for FreeStyle Libre 3 04/17/2023

Avenue Therapeutics Plans IV Tramadol Resubmission 04/17/2023

GSK Plans NDA for Antibiotic Gepotidacin 04/17/2023

FDA ‘Top Cop’ McMeekin Retiring 6/30, Then Many More 04/17/2023

Gamida Cell Therapy Approved by FDA 04/17/2023

Complete Response on Lilly’s Ulcerative Colitis Drug 04/14/2023

High Court Issues 5-day Stay in Abortion Drug Case 04/14/2023

GOP Reps Challenge Generics from ‘Alert’ Firms 04/14/2023

2nd Complete Response on Alvotech Humira Biosimilar 04/14/2023

FDA Wants 2nd Study in Solgenix NDA 04/14/2023

Moximed Knee Shock Absorber Cleared 04/14/2023

Lupin Hit with 13-page 483 at India Plant 04/14/2023

PTA, Specialty Catheter Submission Guidance 04/13/2023

FDA ‘Rewrites’ History, Facts in Coreg Label Case: GSK 04/13/2023

FDA Accepts De Novo AlgoDx Sepis Detector 04/13/2023

FDA Clarifies Philips BiPAP, CPAP Replacement Numbers 04/13/2023

Government Turns to High Court in Mifepristone Appeal 04/13/2023

Guide on OTC Monograph Order Requests 04/13/2023

Panels to Consider Rexulti sNDA for Alzheimer’s Agitation 04/13/2023

Texas House Approves Drug Import Bill 04/13/2023

Pilot Program on Radiation Sterilization Master Files 04/12/2023

Format/Content of OTC Monograph Order Request 04/12/2023

Assessing Adhesion with Transdermal Systems 04/12/2023

Pragmatica-Lung Study Launches 04/12/2023

Omega Packaging CGMP Violations 04/12/2023

Class 3 Device Changes Up Recall Risk: Study 04/12/2023

Vanda Wants Teva Generic Hetlioz Pulled 04/12/2023

Transdermal Irritation/Sensitization Assessment 04/12/2023

Both Sides Argue Over Jurisdiction in Abortion Case 04/12/2023

Safety Alert on O&M N95 Respirators 04/12/2023

Clinical Trial Monitoring Q & A Guide 04/11/2023

Partial Hold on Molecular Templates Study 04/11/2023

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