Examples of F&D Act in a sentence
Consequently, PDVs may constitute food.Foods receive special treatment within the F&D Act.
Under cl 15 of Sch 4 of the 1973 FD Act, a person who was entitled to special use rightsunder a strata scheme regulated by the 1961 Act could apply for a special by- law under the 1996 Management Act.
The Health Products and Food Branch (HPFB) of Health Canada administers the F&D Act and FDRs, sets policies and standards for ensuring a safe food supply, conducts health risk as- sessments and advises CFIA on the safety of packaging materials.
A Rolex ad itself says the watch was voted ‘most likely to be coveted.' Indeed, one of advertising's purposes is to create an aura for a product, so that other people will be impressed.
Based on our experience, we expect that NDA holders will implement safety-related labeling changes requested by FDA even if not required under section 505(o)(4) of the FD Act.
In circumstances in which section 505(o)(4) of the FD Act does not apply, if the NDA holder declined to submit a supplement to make the change that FDA has concluded is appropriate, FDA would consider whether the NDA holder's failure to update its labeling would warrant the initiation of proceedings to withdraw approval of the NDA (see section 505(e) of the FD&C Act).
We recognize that the authority to order safety labeling changes under section 505(o)(4) of the FD Act for new safety information about a risk of a serious adverse drug experience will not apply to all potential safety-related labeling changes (see 21 U.S.C. 355-1(b) defining “new safety information” and “serious adverse drug experience”).
Whereas, the F&D Act, applies the term drugs, which it defines to include substances used in the “prevention of a disease”.47 Each of these definitions encompass vaccines applied to prevent diseases in humans.
In the event that the NDA holder for the RLD does not submit a supplement seeking approval for a related or conforming labeling change, FDA may send a supplement request letter to the NDA holder or, if appropriate, notify the responsible person of new safety information under section505(o)(4) of the FD Act (see 21 U.S.C. 355(o)(2)(A) defining “responsible person”).
It is therefore prudent that the change team to work in a cooperative, coordinated manner, exhibit commitment and lead by example to teach and model the change they advocate.