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FAQ
WHO IS REQUIRED TO SUBMIT AN IND?
1. The IND is a requirement for all persons and firms seeking to ship unapproved drugs across state lines for use in clinical investigations. However, the FDA does offer exemptions from IND submission requirements for certain types of clinical testing on products.
IS THE NEW EU CLINICAL TRIAL DIRECTIVE NOW IN EFFECT?
2. The New EU Clinical Trial Directive became effective as of May, 2004.
THROUGHOUT THE NDA REVIEW PROCESS, AS SPONSOR, CAN I REQUEST MEETINGS WITH THE REVIEWING TEAM?
3. Depending on the drug, the sponsor may be eligible throughout the NDA review process to request various meetings with the reviewing team. Optionally, these meetings can be conducted by videoconference, teleconference, or face-to-face.
HOW DO I KEEP ABREAST OF CURRENT TRENDS IN REGULATORY AFFAIRS IN THE EUROPEAN UNION?
4. To keep abreast of the current RA trends in the EU, log on to the following websites: http://www/emea.eu.int/Press%20Office/presshome.htm and http://pharmacos.eudra.org/F2/pharmacos/new.htm.
HOW DO I KEEP ABREAST OF CURRENT TRENDS IN US OR OTHER COUNTRY REGULATORY INFORMATION?
5. To keep abreast of the current RA trends in the US and other countries, click on useful links on this website and it will take you directly to the websites for US FDA and other countries in Europe, Asia/Oceania, Americas, Africa, and the Middle East. Other useful links for regulatory information such as RAPS, DIA, WHO & ICH are also provided.
HOW CAN I OBTAIN TRANSLATION OF REGULATORY INFORMATION?
6. Translation of regulatory and other information obtained from this website is available in German, French, Italian, Japanese, Simplified Chinese, Spanish, and American English. This can be ontained by clicking on the appropriate country flag on the first page of this website.
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