FDA Order to Restrict Bayer’s Essure Use 04/09/2018

Draft Guide on Expanded Abbreviated 510(k) Program 04/12/2018

Final Guidance on Special Protocol Assessments 04/13/2018

2 New Genetic Disease-Based Test Guidances 04/12/2018

NJ Court Hands Down $33 Million Verdict Against Bard 04/13/2018

Performance Criteria for 510(k) Equivalence 04/11/2018

12 Observations in Celltrion FDA-483 04/13/2018

‘Breakthrough’ Designation Can Be Misleading: Researchers 04/12/2018

Guide on Ultrasonic Diathermy Device 510(k)s 04/13/2018

4 ICH Guidances Announced 04/11/2018

$2.4 Billion in Health Care Fraud Judgments, Settlements 04/11/2018

Latest Federal Register Notices 04/15/2018

Product Approval Summaries 04/15/2018

Since Our Last Issue ... 04/15/2018

FDA Probing Unauthorized Herpes Research 04/12/2018

Collegium Wants Oxycodone ER Restrictions 04/11/2018

13 Observations in Alkem FDA-483 04/11/2018

Innovative Health Wants NSS-2 Bridge Restrictions 04/11/2018

CGMP Violations at Tris Pharma 04/10/2018

Hemophilia Patient Group Asks for Hemlibra Hearing 04/10/2018

Latest FDA Warning Letters 04/10/2018

FDA Denies Insys’ Syndros Petition 04/10/2018

FDA Issues Pediatric Guidance Addendum 04/10/2018

Ultrasonics Reprocessor Validated for 2 Duodenoscopes 04/10/2018

Alembic Pharmaceuticals FDA-483 Issued 04/10/2018

FDA Expanded Approval for Pacira Pain Drug 04/09/2018