Skip to main content
U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Search help
396 results
  1. Adverse Event Detection, Processing, and Reporting - Registries for Evaluating Patient Outcomes - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK208615
    ... and (3) actually reporting the AE for the comparator product directly to FDA. As standard practice in pharmacovigilance, ...
  2. NLM Digital Collections - Considerations in demonstrating interchangeability with a reference product 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
    resource.nlm.nih.gov/101760108
    ... Extrapolation of Data ................................................................................................................... 14 VII. CONSIDERATIONS REGARDING THE COMPARATOR PRODUCT IN A SWITCHING STUDY OR STUDIES....................................................................................... 16 VIII. ...
  3. NLM Digital Collections - Questions and answers on biosimilar development and the BPCI Act 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2021
    resource.nlm.nih.gov/9918351277506676
    ... A sponsor may use a non-U.S.-licensed comparator product in certain studies to support a demonstration that ... licensed reference product, and the non- U.S.-licensed comparator product), and is likely to also include bridging clinical ...
  4. NLM Digital Collections - What can the United States learn from pharmaceutical spending controls in France? 
    Publication: [New York, N.Y.] : The Commonwealth Fund, November 2019
    resource.nlm.nih.gov/101758880
    ... value of the new drug compared with a comparator product. The country also prohibits price increases after a ... value of the new drug compared with a comparator product. The country also prohibits price increases after a ...
  5. NLM Digital Collections - E6(R2) good clinical practice : integrated addendum to ICH E6(R1) 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
    resource.nlm.nih.gov/101734075
    ... and Content of Clinical Study Reports). 1.14 Comparator (Product) An investigational or marketed product (i.e., active ... formulation changes are made in the investigational or comparator product(s) during the course of clinical development, the results ...
  6. Appendices - Surgical site infections: prevention and treatment - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK550390
    ... chlorhexidine and neomycin cream (Naseptin), octenisan and other products Comparator: Different timing of nasal decolonisation compared to each ... chlorhexidine and neomycin cream (Naseptin), octenisan and other products) in combination with body wash using alternative interventions such as: ... nasal decolonisation protocols Outcomes: ...
  7. NLM Digital Collections - Premarket tobacco product applications for electronic nicotine delivery systems 
    Publication: Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, June 2019
    resource.nlm.nih.gov/101760254
    ... appropriate hazard identification comparison, you should include the comparator products (e.g., products in the same category) in ... from a toxicology perspective relative to any similar comparator tobacco products (when those products are used in the same ...
  8. NLM Digital Collections - Allergic rhinitis : developing drug products for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
    resource.nlm.nih.gov/101734438
    ... comparison. Sponsors will likely need to develop monotherapy comparator products specifically for the purposes of the combination product ...
  9. Appendices - Cannabis-based medicinal products - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK552225
    ... interventions above were classed as cannabis-based medicinal products. Eligibility criteria – comparator Placebo Outcomes Participant reported pain relief of 30% ...
  10. NLM Digital Collections - Oral immunotherapy and Viaskin Peanut for peanut allergy : effectiveness and value : final ... 
    Publication: [Boston, Massachusetts] : Institute for Clinical and Economic Review, July 10, 2019
    resource.nlm.nih.gov/9918401083906676
    ... follows: • AR101 • Viaskin Peanut • OIT with other peanut products Comparators Each of the interventions is compared to standard ... care consultancy income from the manufacturer of the product or comparators being evaluated. ©Institute for Clinical and Economic Review, ...
first · previous · 1 · 2 · 3 · 4 · 5 · 6 · 7 · 8 · 9 · 10 · next · last