Part 2 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA regulations with the Common Rule – Comment Period Extended until December
Part 2 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA regulations with the Common Rule – Comment Period Extended until December
December 5, 2022
4
min read
Part 1 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
Part 1 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
November 29, 2022
2
min read
‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)
‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)
November 8, 2022
9
min read
International Group ICH Offers Detailed Protocol Template For Clinical Trials
International Group ICH Offers Detailed Protocol Template For Clinical Trials
November 7, 2022
2
min read
New FDA ‘TAP’ Pilot Wants To Help Companies Traverse ‘Valley Of Death’ By Streamlining The Product Clearance Process. First Up: Cardiovascular Devices
New FDA ‘TAP’ Pilot Wants To Help Companies Traverse ‘Valley Of Death’ By Streamlining The Product Clearance Process. First Up: Cardiovascular Devices
October 13, 2022
3
min read
Seeing Red (And Yellow): Notified Body BSI’s ‘Scorecard’ Shows Plenty Of Work Needed To Meet E.U.’s 19-Point MDR/IVDR Compliance Plan (1 Of 2)
Seeing Red (And Yellow): Notified Body BSI’s ‘Scorecard’ Shows Plenty Of Work Needed To Meet E.U.’s 19-Point MDR/IVDR Compliance Plan (1 Of 2)
October 12, 2022
7
min read
Gimme ‘MORE’: U.K.’s MHRA Wants Adverse Events From Device Makers Via ‘New’ MORE Portal
Gimme ‘MORE’: U.K.’s MHRA Wants Adverse Events From Device Makers Via ‘New’ MORE Portal
October 7, 2022
2
min read
Kiss Your CDs And Thumb Drives Goodbye: FDA Will Accept Only Electronic 510(k) Submissions Next Year
Kiss Your CDs And Thumb Drives Goodbye: FDA Will Accept Only Electronic 510(k) Submissions Next Year
September 23, 2022
2
min read
Combo Drug/Device Products: FDA Notice Aims To Reduce Manufacturer Burden
Combo Drug/Device Products: FDA Notice Aims To Reduce Manufacturer Burden
September 15, 2022
3
min read