30 Cited authorities

Bell Atl. Corp. v. Twombly
550 U.S. 544 (2007) Cited 267,097 times 365 Legal Analyses
Holding that a complaint's allegations should "contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face' "
Chevron U.S.A. v. Natural Res. Def. Council
467 U.S. 837 (1984) Cited 16,024 times 504 Legal Analyses
Holding that courts "must give effect to the unambiguously expressed intent of Congress"
Whitmore v. Arkansas
495 U.S. 149 (1990) Cited 2,854 times 16 Legal Analyses
Holding that a third party does not have "standing to challenge the validity of a death sentence imposed on a capital defendant who has elected to forgo his right of appeal"
National Cable Telecom. Assn. v. Brand X Internet S
545 U.S. 967 (2005) Cited 1,176 times 41 Legal Analyses
Holding that an agency is free within "the limits of reasoned interpretation to change course" only if it "adequately justifies the change"
Texas v. United States
523 U.S. 296 (1998) Cited 1,472 times 3 Legal Analyses
Holding that a claim that "rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all" is not ripe for adjudication
Abbott Laboratories v. Gardner
387 U.S. 136 (1967) Cited 5,287 times 9 Legal Analyses
Holding that plaintiffs subject to a regulation had standing to challenge it even though the Attorney General had yet to "authorize criminal and seizure actions for violations of the statute"
Federal Trade Commission v. Standard Oil Co.
449 U.S. 232 (1980) Cited 614 times 3 Legal Analyses
Holding that the issuance of an administrative complaint is not final agency action because a complaint is "not a definitive statement of position" but instead a "threshold determination that further inquiry is warranted"
Thompson v. Western States Medical Center
535 U.S. 357 (2002) Cited 213 times 14 Legal Analyses
Holding that a ban on advertising the compounding of pharmaceuticals violated the First Amendment
Ewing v. Mytinger Casselberry
339 U.S. 594 (1950) Cited 375 times 4 Legal Analyses
Holding that the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 334, as amended, which permitted seizures of misbranded articles without a hearing, did not violate due process principles, given the risk presented to public health by such misbranded articles
Columbia System v. U.S.
316 U.S. 407 (1942) Cited 392 times 2 Legal Analyses
Holding that agencies are bound to follow regulations on which individuals justifiably rely
Section 704 - Actions reviewable
5 U.S.C. § 704 Cited 4,251 times 31 Legal Analyses
Granting judicial review over " final agency action"
Section 355 - New drugs
21 U.S.C. § 355 Cited 2,246 times 338 Legal Analyses
Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"
Section 321 - Definitions; generally
21 U.S.C. § 321 Cited 1,167 times 165 Legal Analyses
Defining “new drug”
Section 337 - Proceedings in name of United States; provision as to subpoenas
21 U.S.C. § 337 Cited 667 times 19 Legal Analyses
Restricting FDCA enforcement to suits by the United States
Section 343 - Misbranded food
21 U.S.C. § 343 Cited 569 times 59 Legal Analyses
Setting labeling requirements for food products
Section 353 - Exemptions and consideration for certain drugs, devices, and biological products
21 U.S.C. § 353 Cited 299 times 20 Legal Analyses
Requiring a prescription drug label to bear the symbol "Rx only"
Section 371 - Regulations and hearings
21 U.S.C. § 371 Cited 260 times 8 Legal Analyses
Granting the FDA general authority to promulgate regulations for administration of the Food, Drug, and Cosmetic Act
Section 348 - Food additives
21 U.S.C. § 348 Cited 90 times 11 Legal Analyses
Explaining that a food additive is not deemed unsafe for purposes of 21 U.S.C. § 342(C) and that a food will not be considered adulterated where there is in effect a regulation issued prescribing the conditions under which the additive may be safely used
Section 360ee - Grants and contracts for development of drugs for rare diseases and conditions
21 U.S.C. § 360ee Cited 12 times 8 Legal Analyses
(a) Authority of Secretary The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in (1) defraying the costs of developing drugs for rare diseases or conditions, including qualified testing expenses, (2) defraying the costs of developing medical devices for rare diseases or conditions, (3) defraying the costs of developing medical foods for rare diseases or conditions, and (4) developing regulatory science pertaining to the chemistry,
Section 101.9 - Nutrition labeling of food
21 C.F.R. § 101.9 Cited 139 times 47 Legal Analyses
Recognizing that "Vitamin C" and "Ascorbic acid" are "synonym" that may be used in the alternative in a product's nutritional information labeling
Section 201.100 - Prescription drugs for human use
21 C.F.R. § 201.100 Cited 47 times 9 Legal Analyses
Exempting certain approved and new drugs from the FDCA's labeling requirements for adequate directions for use
Section 10.85 - Advisory opinions
21 C.F.R. § 10.85 Cited 44 times 3 Legal Analyses
Providing that an FDA employee's written statement, which constitutes "an informal communication," "does not necessarily represent the formal position of FDA," a statement that by its terms contemplates that certain employee statements may do so
Section 170.3 - Definitions
21 C.F.R. § 170.3 Cited 22 times 4 Legal Analyses
Defining "safe" as "a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use"
Section 170.30 - Eligibility for classification as generally recognized as safe (GRAS)
21 C.F.R. § 170.30 Cited 11 times 7 Legal Analyses
In 21 C.F.R. § 170.30, the FDA establishes how a food additive may be classified as GRAS and notes, in 21 C.F.R. § 182.1(a) and (d), that "[i]t is impracticable to list all substances that are [GRAS] for their intended use" but that many substances that are GRAS "are listed in this part."

Health Science Funding, LLC v. the United States Food & Drug Administration et al

30 Cited authorities

Holding that a complaint's allegations should "contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face' "

Holding that courts "must give effect to the unambiguously expressed intent of Congress"

Holding that a third party does not have "standing to challenge the validity of a death sentence imposed on a capital defendant who has elected to forgo his right of appeal"

Holding that an agency is free within "the limits of reasoned interpretation to change course" only if it "adequately justifies the change"

Holding that a claim that "rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all" is not ripe for adjudication

Holding that plaintiffs subject to a regulation had standing to challenge it even though the Attorney General had yet to "authorize criminal and seizure actions for violations of the statute"

Holding that the issuance of an administrative complaint is not final agency action because a complaint is "not a definitive statement of position" but instead a "threshold determination that further inquiry is warranted"

Holding that a ban on advertising the compounding of pharmaceuticals violated the First Amendment

Holding that the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 334, as amended, which permitted seizures of misbranded articles without a hearing, did not violate due process principles, given the risk presented to public health by such misbranded articles

Holding that agencies are bound to follow regulations on which individuals justifiably rely

Granting judicial review over " final agency action"

Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

Defining “new drug”

Restricting FDCA enforcement to suits by the United States

Setting labeling requirements for food products

Requiring a prescription drug label to bear the symbol "Rx only"

Granting the FDA general authority to promulgate regulations for administration of the Food, Drug, and Cosmetic Act

Explaining that a food additive is not deemed unsafe for purposes of 21 U.S.C. § 342(C) and that a food will not be considered adulterated where there is in effect a regulation issued prescribing the conditions under which the additive may be safely used

Recognizing that "Vitamin C" and "Ascorbic acid" are "synonym" that may be used in the alternative in a product's nutritional information labeling

Exempting certain approved and new drugs from the FDCA's labeling requirements for adequate directions for use

Providing that an FDA employee's written statement, which constitutes "an informal communication," "does not necessarily represent the formal position of FDA," a statement that by its terms contemplates that certain employee statements may do so

Defining "safe" as "a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use"

In 21 C.F.R. § 170.30, the FDA establishes how a food additive may be classified as GRAS and notes, in 21 C.F.R. § 182.1(a) and (d), that "[i]t is impracticable to list all substances that are [GRAS] for their intended use" but that many substances that are GRAS "are listed in this part."