<< Prev  29 30 31 32 33 34 35 36 37 38 39 40 41 Next >>

Jail for 2 Women in Clinical Trial Data Case 10/19/2022

Quality System, Other Violations at Forcemech 10/18/2022

New FDA Rare Disease Grants, Contracts 10/18/2022

CDRH Proposes 18 FY 2023 Guidances 10/18/2022

Too Few Older Adults in Trials: Study 10/18/2022

Changes Urged in ANDA Amendments Appendix 10/18/2022

Califf Still Seeking Revamp of Accelerated Approval 10/18/2022

Multiple Violations at Beijing Xinggu Lvsan 10/18/2022

Draft Guide on Tissue Agnostic Drug Development 10/17/2022

Guide on Immune-mediated Adverse Reactions 10/17/2022

Medtronic Modifies Software for HeartWare Pump Problem 10/17/2022

Guide on Acute Myeloid Leukemia Therapies 10/17/2022

Review on Biogen Lou Gehrig’s Drug Extended 10/17/2022

2 Inspection Program Guides Revised 10/17/2022

‘Missed Opportunity’ on FDA Reforms: Ex-Commissioners 10/14/2022

Guide on ANDA Prior Approval Supplements 10/14/2022

Ulrich Medical 3D-printed Flux-C Cleared 10/14/2022

Travere Expecting 3-month NDA Review Extension 10/14/2022

Revive Therapeutics Amends Protocol on Covid Therapy 10/14/2022

CMS Working with FDA on New Device Coverage Rule 10/13/2022

FDA Revamping NDA/BLA Information Requests 10/13/2022

Three Charged with Falsifying Clinical Trial Data 10/13/2022

FDA Publishes ICH E19 Guideline 10/13/2022

FDA Seeks Covis Info for Makena Hearing 10/13/2022

GSK Respiratory Syncytial Virus Vaccine ‘Highly Efficacious’ 10/13/2022

FDA Says Adderall is in Shortage 10/13/2022

CMC Comparability Protocol Guidance 10/13/2022

Distributed Manufacturing Discussion Paper 10/13/2022

OPDP Wants to Research Drug Name Interpretation 10/13/2022

Regener-Eyes Illegally Selling Dry Eye Product 10/12/2022

FDA Lowers Covid Bivalent Booster Age 10/12/2022

17 Observations on Empower Pharmacy FDA-483 10/12/2022

Rolling NDA Filed for OTC Opioid Overdose 10/12/2022

Is FDA Relying More on ‘Confirmatory Evidence’? 10/12/2022

Merck, Moderna Developing Personalized Cancer Vaccine 10/12/2022

Chinese Firm Recalls ‘Unauthorized’ Covid-19 Tests 10/12/2022

FDA Launches TAP Pilot 10/11/2022

Legacy Pharmaceutical CGMP Violations 10/11/2022

Comment Deadline Extended for LASIK Labeling Guidance 10/11/2022

FDA Loses Court Case Over Generic Minocin 10/11/2022

FDA Proposes to Deny Hetlioz sNDA 10/11/2022

More Quality Issues at Lilly Plant: Reuters 10/11/2022

CGMP Violations at Mexico’s Eksa Mills 10/11/2022

FDA Rejects Supernus NDA for Parkinson’s Drug 10/10/2022

Data Backs Pulmonary Hypertension Drug: Merck 10/10/2022

scPharmaceuticals Gets Heart Failure Drug Approved 10/10/2022

FDA Clears Zeiss Medical’s Bipolar Forceps 10/10/2022

FDA Clears Copan Diagnostics’ Colibrí 10/10/2022

Miscarriage Management Needed on Mifeprex Label: Petititon 10/07/2022

Glaxo’s Boostrix OK’d for Unborn in Third Trimester 10/07/2022

Alnylam Gains Expanded Label for Oxlumo 10/07/2022

FDA Wants Makena Withdrawn While New Trial Conducted 10/07/2022

Fresenius Recalls Ivenix Infusion Pump 10/07/2022

FDA Steps to Harmonize with HHS Common Rule 10/06/2022

Ways to Improve FAERS Signal Review 10/06/2022

AATD Consortium Partnership Launched 10/06/2022

Essure Postmarket Study ‘Inadequate’: FDA 10/06/2022

Lilly Fast Track for Obesity Drug 10/06/2022

FDA Needs More Postmarket Commitment Authority: Study 10/06/2022

2 Final Post-Approval Activity Guidances 10/06/2022

Roche’s Pathway Test OK’d for Low HER2 10/05/2022

IR, DRL Guidance 10/05/2022

Competitive Generic Therapies Guidance 10/05/2022

Glaxo Lung Cancer Phase 2 Trial Meets Endpoint 10/05/2022

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

<< Prev  29 30 31 32 33 34 35 36 37 38 39 40 41  Next >>