21 C.F.R. §201.302 - Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil

Cite as21 C.F.R. §201.302
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2 cases
  • In re Amarin Corp. PLC Sec. Litig., Case No. 3:19-cv-06601 (BRM) (TJB)
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • 29 Marzo 2021
    ...the placebo arm in the REDUCE-IT trial, the allegations in the Sklar Action regarding the use of mineral oil as a placebo, Regulation 21 C.F.R. 201.302(G)(a) (2018), and recent failed cardiovascular studies of omega-3 products. (Id. ¶ 83.) Plaintiffs allege these statements were misleading ......
  • Ex parte Shlieout, Appeal 2020-005326
    • United States
    • United States Patent and Trademark Office. United States Patent and Trademark Office, Patent Trial and Appeal Board
    • 2 Abril 2021
    ...products and have provided advice concerning specific pharmaceutical excipients (see e.g. U.S. Code of Federal Regulations, 21 CFR §201.302), such mineral oil. It is recommended today that mineral oil not be provided indiscriminately to either pregnant women or infants. (Spec. 1:19-26.) We ......
1 firm's commentaries
  • FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
    • United States
    • LexBlog United States
    • 12 Octubre 2009
    ...of fanciful drug or ingredient names that falsely imply that the drug or ingredient has some unique effectiveness or composition); 21 CFR 201.302(c) (prohibiting implied claims that drugs for internal use that contain mineral oil are for administration to infants). The agency has also regul......

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