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HHS OHRP Amends Protections of Human Research Subjects Rule for Specified Populations | Insights

Holland & Knight
The Final Rule immediately implements technical changes to align the protections for pregnant women, human fetuses and neonates, prisoners and children.
2 months ago

Study finds two classes of plant enzymes that ignore common rule of evolution

Phys.org
CSLD enzymes and the microfibrils they produce are also essential for pollen tube development and root hair growth in plants. Pollen tubes are...
3 weeks ago

Federal mandate has improved availability of consent forms for clinical trials

Penn State University
UNIVERSITY PARK, Pa. — A federal regulation called the Common Rule previously requested the public posting of participant consent forms to...
6 months ago

Simplifying the Review Process: A Guide to the FDA's Proposed Single IRB Requirement

FierceBiotech
To comply with the 21st Century Cures Act,1 the Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs).
3 months ago

Guidance for Industry

Food and Drug Administration (.gov)
This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects.
10 months ago

EU common charger rules: Power all your devices with a single charger

European Commission
The EU has implemented a universal charger for electronic devices to reduce waste. All new devices sold in the EU must now support USB-C...
1 month ago

Conservation Groups Take Legal Action to Defend Common Sense Land Management Rule - 7.26.24

Southern Utah Wilderness Alliance
Conservation Groups Take Legal Action to Defend Common Sense Land Management Rule – 7.26.24 · BLM's webpage on the Public Lands Rule. · SUWA's...
6 months ago

Committee Pressure Leads to Withdrawal of BIDEH Rule, Members Thankful for Return to Common Sense

House Committee on Natural Resources (.gov)
The US Fish and Wildlife Service (USFWS) announced the withdrawal of their proposed Biological Integrity, Diversity, and Environmental Health (BIDEH) rule.
1 month ago

NTIA Seeks Approaches to Conduct Ethical Research of Online Services

Tech Policy Press
The National Telecommunications and Information Administration (NTIA) is seeking public input on ethical guidelines for researching online data or “pervasive...
1 month ago

FDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants

Epstein Becker Green
This Insight examines how the draft guidance relates to HHS's “Common Rule” and two of FDA's research-related proposed regulations and...
10 months ago