The document says “is amended”Who acts: CongressHow: statuteSec. 6508 in the PDF
What the document says
“is amended by striking "sponsors or requestors" and inserting "sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding".”
The section amends section 505G(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(h)), which deals with advice the agency gives while a drug is being developed.
What the document actually says
“is amended by striking "sponsors or requestors" and inserting "sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding".”
That sentence, in plain words
Two words are taken out. In their place go words that add groups named by a firm to speak for it.
What this is about
Small firms often work through a trade group. The old words left the group out. Now it can take part.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
The document says “is amended”Who acts: CongressHow: statuteSec. 6508 in the PDF
What the document says
“is amended by striking "requestors" and inserting "sponsors or requestors".”
The correction is to section 505G(b)(2)(A)(iv)(III) of the Federal Food, Drug, and Cosmetic Act. It makes that subclause read like the rest of the section.
What the document actually says
“is amended by striking "requestors" and inserting "sponsors or requestors".”
That sentence, in plain words
One word is taken out. Three words are put in its place.
What this is about
The old text named only one of the two groups. This adds the other. Nothing else about the rule changes.
No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.
Both edits: the widening of who may receive development advice, and the technical correction.
Nothing else. The section is two sentences.
The section works by amending the Federal Food, Drug, and Cosmetic Act. That law is not indexed here, so this file does not say what development advice consists of.
