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FREQUENTLY ASKED QUESTIONS
Q. Who is required to submit an IND?
A. 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.
Q. Is the new EU Clinical Trial Directive now in
effect?
A. The New EU Clinical Trial Directive became effective as of May, 2004.
Q. Throughout the NDA Review Process, as sponsor,
can I request meetings with the reviewing team?
A. 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.
Q. How do I keep abreast of current trends in regulatory
affairs in the European Union?
A. To keep abreast of the current RA trends in the EU, log on to the following website:
Q. How do I keep abreast of current trends in US or other
country regulatory information?
A. 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.
Q. How can I obtain translation of regulatory information?
A. Translation of regulatory and other information obtained from this website
is available. This can be obtained by clicking on the appropriate language from the pulldown menu on the bottom of each page.
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