There is also a way to ask questions:

Here is what the regulations say about the sponsor’s responsibilities for IP labeling. I habe put (a) into bold for your reference:

PART 312 — INVESTIGATIONAL NEW DRUG APPLICATION

Subpart A–General Provisions

Sec. 312.6 Labeling of an investigational new drug.
(a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement “Caution: New Drug–Limited by Federal (or United States) law to investigational use.”

(b) The label or labeling of an investigational new drug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.

(c) The appropriate FDA Center Director, according to the procedures set forth in 201.26 or 610.68 of this chapter, may grant an exception or alternative to the provision in paragraph (a) of this section, to the extent that this provision is not explicitly required by statute, for specified lots, batches, or other units of a human drug product that is or will be included in the Strategic National Stockpile.

[52 FR 8831, Mar. 19, 1987, as amended at 72 FR 73599, Dec. 28, 2007]

I hope this helps,

Carl-

The efficacy guidelines, of which E6 is but one, overlap with one another……..all provide valuable reading for clinical research professionals.

ICH provides a common framework for clinical research irrespective of where we are in the world but has always acknowledged the importance of “applicable regulatory requirements” ……………..BUT when we are applying said regulations do we remember ICH or is it a case of Act local think local rather than Act local think global?

True but let’s put this in context:

(1) Who were the three original sponsors of the ICH process as these were the entities that comprise the ICH Steering Committee so decide which topics would benefit from being harmonised?

(2) How far has each of these co-sponsors gone in terms of codifying guidelines into law or is it more a case of guidelines supporting laws?

(3) What is envisaged by these co-sponsors of ICH as Step 5, implementation in relation to harmonised guidelines

(3) What is meant by guidance or guidelines – should they be ignored as they are not the law?

I think NOT – but let’s here it straight from the horse’s mouth or rather website and then you decide:
[a].http://www.fda.gov/RegulatoryInformation/Guidances/ucm122046.htm

[b]. “Guidance documents accessible from this page represent the Agency’s current thinking on good clinical practice (GCP) and the conduct of clinical trials……..An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.”

[c] “Guidance documents included under the umbrella title of FDA Information Sheets represent the agency’s CURRENT THINKING ON PROTECTION OF HUMAN SUBJECTS IN RESEARCH” (I added the capitals)

Their current thinking……we always want to know what they are thinking so a good starting point is reading ICH E6 which has been with us for more than a decade.

And how many countries have bought into the ICH process? It’s increasingly a case of who hasn’t thanks to activities of ICH’s Global Cooperation Group.