Drugs and Medical Devices: Development and Regulatory Approval
Standard of Care: Clinical Practice Summaries
Health Care Reimbursement
- Centers for Medicare and Medicaid Services - data and reports* CMS Data Navigator
* Medicare Provider Utilization & Payment Data
* CMS Drug Spending
Market Reports, News, Trade Publications
- BCC Research This link opens in a new windowSpecialized market research reports covering healthcare, science, and technology sectors.
- Business Source Complete This link opens in a new windowBusiness magazines, newspapers, and journals.
- Company Websites
Standards
- ISO Standards Catalogue* Try the Online Browsing Platform to preview content.
Device Specifications
- Manufacturer/Vendor Websites* Look for technical manuals and device specifications.
* Information is typically found in a section for healthcare professionals.
Drug Information
- DynaMedex This link opens in a new windowClinical medical reference tool for diseases, disorders, symptoms, treatments, and Micromedex's evidence-based drug information.
- HSL Guide to Finding Drug InformationRecommended resources for different drug information questions, such as adverse effects, bioequivalency, cost, and off-label uses.
Scientific and Patent Publications
- PubMed This link opens in a new window* Biomedical journal articles covering all stages of research and development: target identification, preclinical development, clinical trials, patient care.
* PubMed Search Tips handout - EMBASE This link opens in a new window* Biomedical literature database similar to PubMed, but also includes conference abstracts.
* Good for identifying articles on a particular drug (trade name, non-proprietary name, or lab code), device, or manufacturer. - SciFinder This link opens in a new window* Scientific and patent publications.
* Chemistry, biotechnology, material properties.
* Search for substances or company/patent assignee names. - Engineering Village This link opens in a new window* Journal articles and conference papers on applied science, computer science, and engineering topics.
Clinical Trials
- ClinicalTrials.gov* Information on publicly and privately supported clinical studies from around the world.
* Includes protocols and results for trials that are enrolling, completed, withdrawn, or terminated.
Regulations & Guidelines for Clinical Research and Drug & Device Development
- US Food and Drug Association - Clinical Trials and Human Subject ProtectionRegulations, guidance documents, and information on Good Clinical Practice (GCP).
- ClinRegs (NIH)* Country-specific regulatory information for clinical research.
- International Council on Harmonisation (ICH)* Quality, Safety, and Efficacy Guidelines for worldwide drug development.
Drugs and Biologics - European Medicines Agency
- European Public Assessment Reports (EPARs) for Human MedicinesFull scientific assessment reports of medicines authorised at a European Union level.
Drugs and Biologics - FDA Approval
- Drugs@FDA* FDA-approved human drug products, including prescription and over-the-counter drugs, as well as many biologics.
* Includes approval histories, regulatory reviews, labels, and therapeutic equivalents. - CBER-Regulated Products with Supporting DocumentsCenter for Biologics Evaluation and Research regulated vaccines, blood products, and biologics not included in Drugs@FDA. Caveat: These are products for which CBER has supporting documentation.
- Orange Book: Approved Drug Products with Therapeutic Equivalence EvaluationsFDA-approved generic equivalents, patents, and exclusivity
Medical Devices, Diagnostics, & Mobile Technology - FDA Approval and Clearance
- FDA Premarket Approval (PMA) Database* Class III medical devices approved for marketing by the FDA based on scientific and regulatory review of safety and effectiveness.
* Search for products by name or classification to find summary information. - FDA 510(k) Database* Premarketing submissions made to FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device that is NOT subject to premarket approval
* Search for products by name or classification to find summary information. - Companion Diagnostic Devices Cleared or Approved by the FDAIn vitro diagnostic devices and imaging tools that provide information that is essential for the safe and effective use of a corresponding therapeutic product
- FDA Digital Health Information* Encompasses mobile applications.
FDA Guidance
FDA Educational Modules
- CDER Learn: Training and Education* FDA's educational modules about human drug regulation and activities.
* Case study example: Drug Approval: Bringing a New Drug to the Market. https://www.fda.gov/media/94428/download - CDRH Learn* FDA's educational modules on medical device and radiation emitting product regulations - both premarket and postmarket topics.
* Case study example: How is My Medical Device Classified? https://www.fda.gov/media/131272/download
FDA Information Caveats
- FDA websites do not contain comprehensive approval packages for all FDA-approved drugs, devices, and biologics.
- The amount of information provided in the FDA summary documents varies, and some information is redacted.
- Additional information may be obtained through a Freedom of Information Act request or from FOI Services.