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
Post Jobs
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
Post Jobs
Submit a Press Release
Submit an Event
Search Query
Submit Search
News
Policy
CDRH Updates: Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket 510(k) Submissions
January 27, 2009
|
1 min read
Twitter
LinkedIn
Facebook
Email
Print
Click here to view guidance for industry and FDA staff pertaining to recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions.
Twitter
LinkedIn
Facebook
Email
Print
Regulatory
MORE ON THIS TOPIC
Adcomms
Two AstraZeneca Drugs To Be Scrutinized in First FDA Cancer Advisory Panel in 9 Months
March 9, 2026
·
3 min read
·
Tristan Manalac
Rare diseases
Prasad’s Departure Could Be ‘Big Win’ for Biotech—Especially Rare Disease Space: Analysts
March 9, 2026
·
3 min read
·
Tristan Manalac
Complete response letters
Incyte’s Lung Cancer Expansion Bid Thwarted by Issues at Novo’s Catalent-Acquired Site
March 9, 2026
·
2 min read
·
Tristan Manalac
FDA
FDA’s Prasad To Depart FDA Following Tumultuous Term as CBER Chief
March 6, 2026
·
3 min read
·
Heather McKenzie