Search for: "Matter of Ndi"
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27 May 2010, 7:21 pm
FDA would also be directed to issue guidance that addresses the applicability of the definition of “new dietary ingredient” (NDI) and of the NDI notification submission requirement, among other issues. [read post]
17 Feb 2022, 1:03 pm
ChromaDex submitted NDI notifications for Niagen, but Elysium had not (yet) for Basis. [read post]
16 Jun 2010, 2:40 pm
Downs, Baruch Fischhoff, Giorgio Topa, and Olivier Armantier How Much Does Wealth Matter in the Acquisition of Financial Literacy? [read post]
19 Apr 2023, 5:57 am
Like all criminal cases, these high-profile matters move at different rates and yield different outcomes. [read post]
12 Oct 2018, 10:26 am
Elysium’s “Our Mission” page on its website says that all its products go through various steps, including the “FDA NDI Submission” stage: “We conduct rigorous safety studies for new dietary ingredient (NDI) submissions to the FDA. [read post]
17 Feb 2022, 1:00 pm
The controls, with their innocuous subject matter, did catch respondents “who would reflexively answer that learning the message was false would affect their purchasing decision about any message about the product, no matter how innocuous. [read post]
31 Aug 2011, 2:30 am
X ZR 68/08 (IPKat) Myfortic (Mycophenolate sodium) – US: Novartis and Apotex resolve patent dispute over Myfortic (Patent Docs) Ofirmev (Acetaminophen) – US: Cadence Pharmaceuticals files patent infringement suits in W D North Carolina, W D Michigan, Minnesota and Delaware against Exela, Paddock and Perrigo following Para IV certification (Patent Docs) Patanase (Olopatadine) – US: Alcon files patent infringement suit against Apotex in response to Para IV certification (Patent Docs)… [read post]
5 Apr 2012, 8:46 am
IRI and NDI had been granted permission to monitor the parliamentary elections just before Egyptian prosecutors raided their bureaus, backed by police and military forces carrying machine guns. [read post]
1 Dec 2010, 8:05 pm
[T]he statute’s “willfulness” requirement obligates the government to prove that the defendants knew that disclosing the NDI could threaten the nation’s security, and that it was illegal, but it leaves open the possibility that defendants could be convicted for these acts despite some salutary motive. [read post]
23 May 2023, 5:16 am
In other words, receiving and reporting on NDI could be read to violate the statute. [read post]
9 Jun 2023, 4:52 pm
Nor is it clear that they could be, as both occurred far from the Southern District of Florida where the matter will be tried. [read post]
5 Apr 2024, 1:46 pm
“Plaintiffs’ unfair or deceptive business practice NDI claim may rest upon a theory that even putting the products for sale on the marketplace is an implicit representation that they are being legally sold and comply with the FDA. [read post]
6 Jun 2023, 7:02 am
The government can only classify national security information that has been produced by or for the government and that relates to at least one of several enumerated subject-matter areas. [read post]
18 Aug 2022, 5:01 am
National Defense Information Most official secrets in the United States are what are known as National Defense Information (NDI), which includes anything classified as “Confidential,” or “Secret,” or “Top Secret,” and so on. [read post]
8 Jan 2019, 3:00 pm
We review the following nanotechnology matters, among others, with new medical ventures: Explaining how the FDA regulates nanotechnology “Understanding of related FDA legal rules concerning medical devices, cosmetics, OTC products (such as sunscreens), and new dietary ingredients (NDIs) in dietary supplements” Labeling, production, and handing issues as they relate to FTC rules Additional federal and state governmental regulations Intellectual property protection… [read post]
15 Dec 2018, 9:00 am
” DIETARY SUPPLEMENTS, COSMETICS, MEDICAL DEVICES – WHY SUBSTANTIATING CLAIMS MATTERS Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market – why? [read post]
