SUBSCRIBE
SUBSCRIBE
News   Policy

CDRH Update: Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff

August 4, 2008 | 
1 min read

Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers.

Regulatory
MORE ON THIS TOPIC
Pictured: Facade of Moderna's building in Massachusetts
RSV
Moderna’s RSV Vaccines Run Into Safety Roadblock
December 11, 2024
 · 
2 min read
 · 
Tristan Manalac
Mental health, illness ,brain development ,medical treatment concept, messy lines of thinks in human head , vector illustration
Neurodegenerative disease
UniQure Clears Path to Accelerated Approval for Huntington’s Gene Therapy
December 10, 2024
 · 
2 min read
 · 
Tristan Manalac
A handshake of businessmen. Modern design with a positive context. Concept of help, support, and agreement between businessmen. Modern art collage, trendy magazine style.
Mergers & acquisitions
Novo, Catalent $16.5B Deal Wins EU Blessing as US Antitrust Scrutiny Mounts
December 9, 2024
 · 
2 min read
 · 
Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: Ionis, Lexicon, Bristol Myers Squibb and More
December 9, 2024
 · 
7 min read
 · 
Tristan Manalac