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Comments on Fit-For-Purpose Draft Guidance 09/27/2022

OTC Monograph Submission Format Guidance 09/27/2022

FDA Changing Covid Test Review Policy 09/27/2022

Clinical Decision Software Guidance 09/27/2022

CGMP Deviations at Zhejiang Tianyu Pharmaceutical 09/27/2022

Tissues Office Renamed Office of Therapeutic Products 09/27/2022

Value in Leveraging Clinical Pharmacology Principles 09/27/2022

Generic Drug Safety Labeling Legislation 09/27/2022

Pediatric Extrapolation is Expanding: Study 09/27/2022

‘Clean’ User Fee Bill Added to Continuing Resolution 09/27/2022

Comments on Remote Assessment Guidance 09/27/2022

Calcium Carbonate OK for Use in Supplements 09/26/2022

New Regulatory Paradigm Needed for Device Software: FDA 09/26/2022

Naloxone Guidance Attempts to Ease Availability 09/22/2022

Expand RTOR to Cell, Tissue Products: PhRMA 09/22/2022

Comments on Therapeutic Equivalence Draft Guidance 09/22/2022

OPDP to Study TV Ad Endorsers 09/22/2022

User Fee Reauthorization Agreement Reached in Senate 09/22/2022

Accelerated Approval On- and Off-Ramp Approaches 09/22/2022

Panel Votes Down Spectrum Lung Cancer Drug 09/22/2022

DoJ Increasing Corporate Enforcement 09/21/2022

5 Observations in Cipla FDA-483 09/21/2022

OIG Identifies FDA Emergency Use Authorization Issues 09/21/2022

FDA Approves Pedmark for Cisplatin Ototoxicity 09/21/2022

FDA Stepping Up Drug Inspections in India 09/20/2022

Government Not Using Park Doctrine Enough: Study 09/20/2022

BioLab Sciences Illegally Selling Products: FDA 09/20/2022

FDA Reviewers Question Spectrum’s Pozenveo 09/20/2022

Agency Questions Confirmatory Study for Pepaxto 09/20/2022

Year-One Report on the Generic Drug Cluster 09/20/2022

Vanda Agrees to Pay Over $11 Million in Off-label Suit 09/19/2022

FDA Reminds on Endotracheal Tube Obstructions 09/16/2022

HHS Outlines FDA Projects Under Biotech Initiative 09/16/2022

Akorn Pays $7.9 Million to Resolve False Claims Suit 09/15/2022

Top FDA-483, Warning Letter Observations 09/15/2022

FDA Grants, Denies Catalyst Amifampridine Petition 09/15/2022

Novartis Wants Restrictions on Entresto ANDAs 09/15/2022

FDA Challenges Illicit Trade Workshop Attendees 09/15/2022

Baxter Clearlink Solution Set Recall is Class 1 09/15/2022

Advisors to Discuss Pulse Oximeter Accuracy 09/15/2022

Elemental Impurities Guidance 09/15/2022

FDA Rejects Hearing Aid Standardization 09/14/2022

FDA Partnership on Rare Neurodegenerative Diseases 09/14/2022

Bob Temple Gets New Title, Role Remains the Same 09/14/2022

MAPP on SGEs Representing Sponsors Before FDA 09/14/2022

Affirm Dismissal of Lexapro Case: WLF 09/14/2022

3 Observations on Aurobindo FDA-483 09/14/2022

Texas Longhorn RX Producing Illegal Drugs: FDA 09/13/2022

$2 Million FDA Grant to Marker Therapeutics 09/13/2022

Preserve Access to Compounded Hormones: APC 09/13/2022

ISCT Criticizes Ruling in Cell, Gene Therapy Case 09/13/2022

FDA Report on Generic Drug Approval Cost Savings 09/13/2022

FDA in Pistoia Alliance Working Group 09/13/2022

User Fee Reauthorization Talks Continue 09/13/2022

FDA Denies Petition on Colonoscopy Preparation 09/12/2022

FDA Approves BMS Plaque Psoriasis Drug 09/12/2022

Biomarin Reports Leukemia in Patient on Gene Therapy 09/12/2022

Boston Imaging V7 Ultrasound Cleared 09/09/2022

FDA Taps PATH’s Kaslow as Vaccine Chief 09/09/2022

Pfizer NDA for Alopecia Drug Accepted for Review 09/09/2022

RWD, RWE Submission Guidance 09/08/2022

FDA Denies 2014 LASIK Petition 09/08/2022

UCS Surveying State of Science Under Biden 09/08/2022

FDA Breast Implant Cancer Alert 09/08/2022

FDA Emergency Monkeypox Test Guidance 09/08/2022

Panacea Biotec Inspection is OAI 09/08/2022

Safety Alert on Abbott’s MitraClip Delivery Systems 09/08/2022

Nonprescription Drug Label Guidance 09/08/2022

7 Observations in Korea’s Hugel FDA-483 09/07/2022

Pharmacology Pediatric Studies Guidance 09/07/2022

CDER, CBER Accept 1st ISTAND Submission 09/07/2022

Stakeholders Want Changes to Supply Chain Guidance 09/07/2022

Pacira Seeking Expanded Label on Exparel 09/07/2022

FDA Lifts Hold on Sarepta Duchenne Drug Trial 09/06/2022

Leaf of Life Marketing Illegal New Drugs: FDA 09/06/2022

Boston Scientific’s Watchman Gets Revised Label 09/06/2022

CDER Working to Optimize Drug Absorption 09/06/2022

FDA Denies Most of Salix Xifaxin Petition 09/06/2022

Bayer Paying $40 Million to Settle 2 Whistleblower Suits 09/06/2022

Advancing Regulatory Science at FDA 2022 Report 09/06/2022

FDA Approves Fresenius Kabi Biosimilar 09/06/2022

FDA Approves Boehringer Pustular Psoriasis Drug 09/02/2022

Imfinzi Approved for Biliary Tract Cancer 09/02/2022

FDA Observations from 3 Biocon Biologics Inspections 09/01/2022

Cue Health Seeks De Novo for At-Home Flu Test 09/01/2022

GDUFA Research Supports Generic Drug Development 09/01/2022

FDA, C-Path Exploring Lysosomal Diseases Group 09/01/2022

Respironics Troubles Broaden as it Pays $24 Mil. Over False Claims 09/01/2022

Integra CereLink Monitor Recall is Class 1 09/01/2022

FDA’s ‘Whole-of-Government’ Approach to Illicit Products 09/01/2022

Former Pharmatech CEO Gets 37 Months in Jail 09/01/2022

Beam To Complete Clinical Hold Studies This Year 08/31/2022

FDA OKs Genzyme’s Xenpozyme for ASMD 08/31/2022

Changes Sought in Drug Shortage Draft Guidance 08/31/2022

CGMP Violations at Green Wave Analytical 08/30/2022

Priority Review for Sanofi’s Efanesoctocog Alfa 08/30/2022

Device Cybersecurity Firm Hires Former FDA Reviewer 08/30/2022

Multiple Violations at Elite One Source 08/30/2022

Lessons Learned from PPI Case Studies 08/30/2022

FDA Introduces Overdose Prevention Framework 08/30/2022

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