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No Pre-EUA for Eiger Covid Treatment 10/05/2022

Post-CRL Clarification Teleconference Guidance 10/05/2022

Reject Novel Liability Theory for Rx Drugs: WLF 10/05/2022

4 CBER SOPPs on Application Processing 10/05/2022

Bayer Reiterates Position on Apotex ANDA 10/05/2022

Manufacturing Woes Lead to Natpara Discontinuation 10/04/2022

Rare Disease Endpoint Advancement Pilot 10/04/2022

Flawless Beauty and Skin Selling Illegal Products: FDA 10/04/2022

CGMP Violations at Sterling Pharmaceutical 10/04/2022

U.S. Gov’t Asked to Weigh in on Skinny Label Case 10/04/2022

Accelerated Approval Transforms Precision Oncology: Study 10/04/2022

510(k), De Novo, PMA Review Clock Guidances 10/04/2022

Guide on ANDA Facility Readiness and Goal Dates 10/03/2022

Guide on Generic Drug Size and Shapes 10/03/2022

Lupin Gets Warning Letter After Inspection 10/03/2022

Increased Covid Risk For Those on Evusheld: FDA 10/03/2022

FDA Funds Biosimilar Research to Boost Development/Review 10/03/2022

GE Healthcare Gets AIR Recon Imaging Clearance 10/03/2022

User Fee Reauthorization Signed Into Law 09/30/2022

Senate OKs Bill Ending Animal Testing Mandates 09/29/2022

Medtronic’s Hemostasis Agent Cleared for Upper GI 09/29/2022

Amylyx Lou Gehrig’s Disease Drug Approved 09/29/2022

Radiology Display Device Submission Guidance 09/29/2022

Medical Device Data Systems Guidance 09/29/2022

FDA in New AMP Heart Failure Program 09/29/2022

Comments on COA Guidance 09/29/2022

Mfr. Deficiencies Hamper 1st Cycle ANDA Reviews 09/29/2022

Eisai/Biogen Claim Lecanemab Trial Success 09/28/2022

Oncologic Surrogates Rarely Correlate with Survival: Study 09/28/2022

FDA Mobile Medical App Software Policy 09/28/2022

FDA, VA Collaborate to Accelerate Device Innovation 09/28/2022

Comments on Drug Interaction Study Guidance 09/28/2022

FDA Radiology CADe Device Guidance 09/28/2022

FDA Safety Notices Can Affect Liability: Analysis 09/28/2022

Feds Interested in FDA-based False Claims Cases: Attorneys 09/28/2022

Delta Pharma FDA-483 Released 09/28/2022

Comments on Fit-For-Purpose Draft Guidance 09/27/2022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

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