Winter v. Natural Res. Def. Council, Inc.

Holding that a plaintiff must establish "that he is likely to suffer irreparable harm"

List v. Driehaus

Holding that a state government's credible threat of prosecting the plaintiffs under a statute criminalizing false statements about candidates during a political campaign established standing in a facial pre-enforcement challenge

Munaf v. Geren

Holding that civilian U.S. citizens held in U.S. military custody in Iraq could petition for a writ of habeas corpus in federal district court

Ward v. Rock Against Racism

Holding that music is protected expression

Hoffman Estates v. Flipside, Hoffman Estates

Holding that the possible inhibition of a constitutional right is "perhaps the most important factor"

Central Hudson Gas Elec. v. Public Serv. Comm'n

Holding that a restriction on commercial speech must directly advance a substantial governmental interest

Maynard v. Cartwright

Holding that Oklahoma's "especially heinous, atrocious, or cruel" aggravating circumstance was unconstitutionally vague

Sorrell v. IMS Health Inc.

Holding that a restriction on "speech result[ing] from an economic motive" is not "a mere commercial regulation"

Board of Trustees, State Univ. of N.Y. v. Fox

Holding that the "least restrictive means" test does not apply to commercial speech cases

Virginia v. American Booksellers Assn

Holding that plaintiffs pleaded Article III injury where they alleged "actual and well-founded fear that the law will be enforced against them," explaining that "alleged danger of this statute is . . . one of self-censorship; a harm that can be realized even without an actual prosecution"

Section 3729 - False claims

Holding liable "any person" who knowingly causes false claims to be presented

Section 301 - Short title

Section 355 - New drugs

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 331 - Prohibited acts

Prohibiting the sale of adulterated foods

Section 321 - Definitions; generally

Defining “new drug”

Section 352 - Misbranded drugs and devices

Setting labeling requirements for drug products

Section 353 - Exemptions and consideration for certain drugs, devices, and biological products

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

Section 371 - Regulations and hearings

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

Section 201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in Section 201.56(b)(1)

Listing requirements for different subsections for indications, dosage, and clinical studies

Section 314.50 - Content and format of an NDA

Recognizing the proprietary nature of DSD and SP specifications by requiring that each ANDA applicant provide its own distinct specifications

Section 201.80 - Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in Section 201.56(b)(1)

Requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”

Section 201.56 - Requirements on content and format of labeling for human prescription drug and biological products

Disallowing claims or suggestions of drug use on labeling if there is a lack of substantial evidence

Section 201.100 - Prescription drugs for human use

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

Section 201.128 - Meaning of "intended uses"

Section 201.5 - Drugs; adequate directions for use

Defining "adequate directions for use" as "directions under which the layman can use a device safely and for the purposes for which it is intended"

Section 202.1 - [Effective until 5/20/2024] Prescription-drug advertisements

Defining labeling to include virtually any type of audio, visual or printed matter descriptive of a drug and supplied by a manufacturer

Section 314.126 - Adequate and well-controlled studies

Stating that among the characteristics of "[a]n adequate and well-controlled study" is that "[a]dequate measures are taken to minimize bias on the part of the subjects, observers, and analysts of the data. The protocol and report of the study should describe the procedures used to accomplish this, such as blinding"

Section 10.115 - Good guidance practices

Setting forth “good guidance practices” for FDA to follow in developing, issuing and using guidance documents, which include notice-and-comment procedures for guidance documents which “[s]et forth changes in interpretation or policy that are of more than a minor nature”