Medmarc Blog (blog.medmarc.com)
Posts about
Informed Consent
Filtered on
- 3D Printing (1)
- 510(k) (10)
- AdvaMed (7)
- Advertising and Promotion (2)
- AI (13)
- Artificial Intelligence (8)
- Breakthrough Devices (7)
- Centers for Medicare & Medicaid Services (CMS) (19)
- Claims and Litigation (1)
- Clinical Trials (15)
- Contract Manufacturing (1)
- COVID 19 (28)
- Cures Act (2)
- Cybersecurity (8)
- Department of Justice (DOJ) (2)
- Draft Guidance (34)
- Drug Prices (1)
- Emergency Use Authorization (EUA) (3)
- European Union (EU) (3)
- FDA (127)
- FDARA (1)
- Food, Drug and Cosmetic Act (FDCA) (3)
- FTC (1)
- Generic Drugs (1)
- Global Solutions (2)
- Health and Human Services (HHS) (13)
- Informed Consent (2)
- Inspections (1)
- Intended Use (2)
- Lab Developed Tests (11)
- Legislation (4)
- Life Sciences Industry (68)
- Machine Learning (6)
- Medical Device (29)
- Medical Device Manufacturers (54)
- Medical Device Regulation (MDR) (8)
- Off Label Promotion (4)
- Patents (3)
- Pharmaceuticals (18)
- PMI (1)
- Predetermined Change Control Plans (PCCPs) (2)
- Premarket Approval (PMA) (8)
- PREP Act (4)
- Products Liability (9)
- Recalls (1)
- Regulatory and Compliance (79)
- Risk Management (13)
- SaMD (4)
- Supply Chains (12)
- Supreme Court (2)
- TCET (2)
- Vaccines (1)
- Warnings and Labels (5)
FDA,
Products Liability,
Clinical Trials,
Informed Consent,
Life Sciences Industry,
Regulatory and Compliance
Navigating the FDA Rule on IRB Waivers for Minimal Risk Trials: Pt. 2 – Products Liability Concerns and the Role of Informed Consent
September
16,
2024
This post is the second in a series that examines the products liability risks associated with the FDA’s new rule that allows Institutional Review Boards (IRBs) to waive informed consent...
FDA,
Products Liability,
Clinical Trials,
Informed Consent,
Life Sciences Industry,
Regulatory and Compliance
Navigating FDA Rule Changes for Minimal Risk Trials: Implications & Best Practices
August
21,
2024
The recent FDA rule change regarding Institutional Review Board (IRB) waivers for minimal risk clinical trials, effective January 22, 2024, allows exceptions from the requirement to obtain...