Medical Technology and Life Sciences Publications | Series: Risk Management 101 (2)

FDA, Risk Management, Series: Risk Management 101, Regulatory and Compliance

When is a Drug or Device Misbranded?

The Federal Food, Drug, and Cosmetic Act ("FDCA") is a federal law that is a primary source for many rules that impact the pharmaceutical and medical device industries. The FDCA's intent...

1 minute read

Risk Management, Clinical Trials, Emerging Growth, Informed Consent, Series: Risk Management 101, For Entrepreneurs

Drafting Informed Consent Forms | Medmarc

The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks of the clinical trial. The informed...

2 minute read

Risk Management, Products Liability, Pharmaceuticals, Series: Risk Management 101, Claims and Litigation

Vaccine Injury Compensation Program

The early to mid-1980s was an era of considerable vaccine-related litigation. In response to increasing litigation costs and damage awards, many vaccine manufacturers left the market....

2 minute read

FDA, Risk Management, Adverse Event Reporting, Series: Risk Management 101, Regulatory and Compliance

Medical Device Reports (MDRs)

The Food and Drug Administration ("FDA") requires medical device companies to report fatal or serious incidents - or potentially fatal or serious incidents - associated with the use of...

1 minute read

Series: Risk Management 101 (2)

Filtered on

When is a Drug or Device Misbranded?

Drafting Informed Consent Forms | Medmarc

Vaccine Injury Compensation Program

Medical Device Reports (MDRs)