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Search for biomedical literature citations. Embase is a key resource for conducting systematic reviews and researching evidence-based medicine. Includes specialized pharmacovigilance, drug/disease, and medical device search interfaces.
Indexes journals, including many not in Medline, from over 90 countries, and indexes conference abstracts from many conferences. Broad biomedical scope with strong coverage in drug, pharmaceutical, and toxicological research including economic evaluation.
Search biomedical literature citations from MEDLINE, life science journals, and online books. [1950 - present]
Access to citations from MEDLINE, PreMEDLINE, other journals in the field of medicine and life sciences, and links to NCBI's integrated molecular biology databases including nucleotide sequences, protein sequences, 3-D protein structure data, population study data sets, and assemblies of complete genomes in an integrated system. Note: The link above goes to a specially configured version of PubMed for UC Berkeley users that will display the Get It button for full text access. To use the free public version, please click here.
Comprehensive database for searching across journal articles, conference papers, and online handbooks in all engineering, computer science, and physics disciplines. Includes Compendex, Inspec, and Knovel. [1884-present]
Compendex is the primary literature database for engineering, Inspec is the primary literature database for physics, astronomy, electronics engineering, and computer science, and Knovel is a collection of engineering, chemistry, and physics handbooks.
Search the world's most comprehensive source of references, substances, and reactions in chemistry and related sciences. Note: Restricted to UC Berkeley students, faculty, and staff. Requires creation of a personal account from an @berkeley.edu email address.
Indexes over 9,000 journals, patents, conferences, books, technical reports and dissertations related to chemistry, chemical engineering, materials science and the biomedical sciences. Relates to the print equivalent Chemical Abstracts. Note: SciFinder-n is the next generation SciFinder platform. You can choose to use either until the old version is phased out, but SciFinder-n includes an updated search algorithm and enhanced features, including synthesis planning
The FDA sets policy and formulates rules and regulations governing how new drugs, medical devices, and more are developed, approved, and brought to market. The scope of the US Food and Drug Administration's regulatory authority is very broad, and includes:
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.
SOPs for Regulatory Applications for the Pharmaceutical Industry
Collection of 11 videos (with PDFs of slides) from The Biomedical & Life Sciences Collection, Henry Stewart Talks on topics such as:
Effective SOP Writing
Procedural assessments of SOPs to ensure SOPs are logical and meet GXP requirements
Using process mapping, forms and templates for the production of SOPs
Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOPs) provide the main forum for the documentation of a pharmaceutical company's systems and operations and compliance with GXP such as GCP, GPV, GMP and GLP.
Public Health Librarian Interim Optometry & Vision Science Liaison
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,
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.
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.
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).