News
Drug Development
FDA
Manufacturing
Deals
Business
Job Trends
Cell and Gene Therapy
Cancer
Opinions
Press Releases
All News & Releases
Podcasts
Events
Jobs
Companies
Hotbeds
More
Reports
Career Advice
NextGen: Top Startups to Watch
40 Under 40
Best Places to Work
Employer Resources
Advertise
Advertise
Talent Solutions
Submit a Press Release
Submit an Event
SUBSCRIBE
Menu
SUBSCRIBE
Show Search
News
Drug Development
FDA
Manufacturing
Deals
Business
Job Trends
Cell and Gene Therapy
Cancer
Opinions
Press Releases
All News & Releases
Podcasts
Events
Jobs
Companies
Hotbeds
More
Reports
Career Advice
NextGen: Top Startups to Watch
40 Under 40
Best Places to Work
Employer Resources
Advertise
Advertise
Talent Solutions
Submit a Press Release
Submit an Event
Search Query
Submit Search
News
Policy
CDRH Update: Federal Register: Humanitarian Device Exemption Regulation: Draft Guidance for Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Questions and Answers
August 5, 2008
|
1 min read
Twitter
LinkedIn
Facebook
Email
Print
Draft Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian Device Exemption Regulation: Questions and Answers; Availability.
Twitter
LinkedIn
Facebook
Email
Print
Regulatory
MORE ON THIS TOPIC
Regulatory
Atara Climbs Amid Report of FDA Inconsistency Leading to Cell Therapy’s Rejection
February 26, 2026
·
1 min read
·
Tristan Manalac
Drug pricing
Trump Calls on Congress To Codify Most Favored Nation Drug Pricing in SOTU
February 25, 2026
·
2 min read
·
Annalee Armstrong
Vaccines
Postponed ACIP Meeting Rescheduled for Mid-March
February 25, 2026
·
3 min read
·
Tristan Manalac
Regulatory
Patient Death Forces Partial Freeze on MacroGenics’ Gynecologic Cancer Study
February 25, 2026
·
2 min read
·
Tristan Manalac
