Environmental Engineering Reference
In-Depth Information
on. the. safety. and,. as. appropriate,. the. effectiveness. of. products.. Other. recommen-
dations. suggest. that. the. FDA. provide. guidance. to. manufacturers. about. when. the.
use.of.nanoscale.ingredients.may.require.submission.of.additional.data,.change.the.
product's.regulatory.status.or.pathway,.or.merit.taking.additional.or.special.steps.to.
address.potential.safety.or.product.quality.issues..The.Task.Force.also.recommends.
seeking.public.input.on.the.adequacy.of.the.FDA's.policies.and.procedures.for.prod-
ucts. that. combine. drugs,. biological. products,. and/or. devices. containing. nanoscale.
materials.to.serve.multiple.uses,.such.as.both.a.diagnostic.and.a.therapeutic.intended.
use..The.Task.Force.also.recommends.encouraging.manufacturers.to.communicate.
with.it.early.in.the.development.process.for.products.using.nanoscale.materials,.par-
ticularly.with.regard.to.such.highly.integrated.combination.products.
...
issue: ability of the Fda to identify Fda-Regulated
Products Containing nanoscale Materials
Recommendations.for.consideration.include:
•
Issue.guidance.to.sponsors.regarding.identiication.of.the.particle.size.for.
products. subject. to. pre-market. authorization,. including. over-the-counter.
(OTC). drugs,. and. food. and. color. additives;. and. products. not. subject. to.
pre-market.authorization.but.for.which.the.sponsor.is.required.to.provide.
notice,.or.may.choose.to.provide.notice.
When.warranted,.issue.a.call.for.data.to.identify:.OTC.drug.products.that.
contain. or. may. contain. nanoscale. versions. of. ingredients. included. in. an.
OTC.monograph;.and.nanoscale.versions.of.previously.approved.food.and.
color.additives.
•
...
issue: scope of the Fda's authority Regarding
ealuation of safety and effectieness
For.products.subject.to.pre-market.authorization:
•
Issue.a.notice.in.the.
Federal Register
.requesting.submission.of.data.and.other.
information. addressing. the. effects. on. product. safety. and. effectiveness. of.
nanoscale.materials.in.products.subject.to.FDA.pre-market.authorization.
Issue.guidance.requesting.submission.of.information.on.whether.and.how.the.
presence.of.nanoscale.materials.affects.the.manufacturing.process.for.prod-
ucts.subject.to.pre-market.authorization,.as.part.of.a.pre-market.submission.
Issue. guidance. or. amend. existing. guidance. to. describe. what. additional.
or.distinct.information.should.be.submitted.to.the.FDA.or.generated.with.
regard.to.the.following:
New.food.or.color.additives.made.with.nanoscale.materials
Previously.approved.food.or.color.additives.that.are.now.made.with.
nanoscale. materials. or. contain. greater. proportions. of. nanoscale.
materials
Issue.guidance.describing.when:
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