OOMPH Library Resources: PHW 236A: Regulatory Science, Drug Development and Public Health: Organizations & Websites

Rules, regulations, dockets, standards, guidance documents, and more.

FDA's Advancing Regulatory Science Initiative builds on the achievements of existing Agency programs to transform the way medical products are developed, evaluated, and manufactured. Regulatory Science-Related Agency Activities include:
- Improving Pediatric and Child Care;
- Developing Products for Global Infectious Disease and Bioterrorism;
- Enhancing Safety and Health Through Informatics;
- Meeting the Challenges for Regulating Tobacco;
- Modernizing Toxicology to Advance Public Health.

These reports contain information on new drug application (NDA), biologic license application (BLA), and abbreviated new drug application (ANDA) approvals. The list also includes a link to investigational new drug (IND) activity reports.

A Catalog of FDA approved and tentatively approved prescription, over-the-counter, and discontinued drugs, and Drug approval letters, labels, and review packages. Searchable by drug name, active ingredient, application number, action dates of application approvals and supplements.

Has information about new and generic drug approvals as well as warning and violation letters.

Search by active ingredient, applicant holder, proprietary name, application number, or patent.

OHRP provides leadership in the protection of the rights, welfare, and well-being of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services. OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research.

The Clinical Research Policy Program focuses on the regulatory and policy issues related to research involving human subjects, biospecimens, participant data, and the integration of bioethical considerations across the NIH research portfolio.

Provides information about federally and privately supported clinical research in human volunteers. Information about a trial's purpose, who may participate, locations, and phone numbers for more details.

NCATS was established to transform the translational process so that new treatments and cures for disease can be delivered to patients faster. Their efforts include pre-clinical innovation, Patient/Community Engagement, and more.

Works to end extreme global poverty and enable resilient, democratic societies to realize their potential.

CIOMS is an international, NGO established jointly by WHO and UNESCO in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations, and works on product development, bioethics, and pharmacovigilance,

A collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected diseases. Information on Target Product Profile, as well as advocacy and capacity building.

EMA is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

Key functions are to assess current knowledge, practice patterns, ongoing studies and information in all areas affecting HIV disease including the basic, clinical and social sciences, public health and health services research.

An open-access collaborative forum for sharing experiences, knowledge and tools relating to pharmacovigilance and other patient/research participant safety-related issues.

ICH brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Site includes trainings and standards.

Information on drug discovery, regulatory systems, innovation, and research. Includes codes of conduct, other publications and news, and the Certification Scheme for a
Certificate of Pharmaceutical Product Toolkit.

Information and publications on access, innovation, regulation, and more.

Allows systematic and large-scale computational analysis of drug biochemistry (metabolic precursors or prodrugs and metabolic fate or degradation), enzymatic targets, and toxicity in the context of cellular metabolism, i.e. currently including: human, Plasmodium (malaria parasite), and E. coli metabolism.

The PQM program helps low- and middle-income countries strengthen the systems that ensure the quality and increase the supply of priority medicines. Information on strengthening the regulatory systems, increasing supply and quality, and the Medicines Quality Database.

Areas of work include pharmacovigilance, substandard and falsified medical products; regulatory systems strengthening; supporting regulatory networks. Site includes guidance, publications and more.

The largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC).

Trial data from across the globe.

A source of financial and technical assistance to developing countries around the world. Offers support to developing countries through policy advice, research and analysis, and technical assistance. Offers free access to comprehensive, downloadable indicator data about development in countries around the globe.