Requirements ⇒ recommendations [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2018-08-01 11:12 (1183 d 19:56 ago) – Posting: # 19120
Views: 7,202

Hi Scopy,

» » Could it be that the May 24 version is the updated and thus the recommended version to use?

Yes.
» » Was also wondering what was the modification done :ponder:

Unfortunately most regulatory documents are published without track changes. Not uncommon that older versions are overwritten (worst example: the EMA’s 15 versions of the Q&A document).

» I have skimmed through both documents. I did not notice any difference …

Not surprising. I used an online tool. Requirement(s) in the version of May 21 changed to recommendation(s):Not unusual for the FDA to give recommendations rather than requirements. However, changing the wording was not consequent. In many places we still read e.g., “the requirements for […] are listed in Table 1.” – where only recommendations are given.

VIII. Glossary, Batch
old:

A batch is a number of unknown samples from one or more patients in a study and QCs that are processed at one time.

new:

For purposes of this guidance, a batch is a number of unknown samples from one or more pati­ents in a study and QCs that are processed at one time.


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