Lujan v. Defs. of Wildlife

Holding that the elements of standing "must be supported in the same way as any other matter on which the plaintiff bears the burden of proof"

St. Mary's Honor Ctr. v. Hicks

Holding that a trier of fact may infer discrimination upon rejecting an employer's proffered reason for termination

Christopher v. Harbury

Holding Verdugo-Urquidez and Eisentrager foreclosed due process claim for actions taken against alien abroad

Landgraf v. USI Film Prods.

Holding that a statute may apply retroactively when "clear congressional intent favor such a result"

Califano v. Sanders

Holding that "the APA is not to be interpreted as an implied grant of subject-matter jurisdiction to review agency actions"

Agostini v. Felton

Holding that "lower courts should follow the case which directly controls, leaving to this Court the prerogative of overruling its own decisions"

McCarthy v. Madigan

Holding that a prisoner was not required to exhaust the Bureau of Prisons' administrative procedure before making a Bivens claim for money damages

Kowalski v. Tesmer

Holding that attorneys lacked third party standing to assert the rights of future, as yet unascertained clients with whom “they ha[d] no relationship at all”

Geier v. Am. Honda Motor Co.

Holding the absence of an express pre-emption clause “does not bar the ordinary working of conflict pre-emption principles”

Federal Election Comm'n v. Akins

Holding that inability to procure information to which Congress has created a right in the Federal Election Campaign Act of 1971 qualifies as concrete injury satisfying Article III's standing requirement

Rule 56 - Summary Judgment

Holding a party may move for summary judgment on any part of any claim or defense in the lawsuit

Rule 15 - Amended and Supplemental Pleadings

Finding that, per N.Y. C.P.L.R. § 1024, New York law provides a more forgiving principle for relation back in the context of naming John Doe defendants described with particularity in the complaint

Rule 52 - Findings and Conclusions by the Court; Judgment on Partial Findings

Recognizing that a "reviewing court must give due regard to the trial court's opportunity to judge the witnesses' credibility"

Section 2201 - Creation of remedy

Granting district courts the authority to create a remedy with the force of a final judgment

Rule 50 - Judgment as a Matter of Law in a Jury Trial; Related Motion for a New Trial; Conditional Ruling

Allowing "renewed motion"

Section 704 - Actions reviewable

Granting judicial review over " final agency action"

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 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 314.70 - Supplements and other changes to an approved NDA

Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

Section 10.25 - Initiation of administrative proceedings

Including forms under 21 C.F.R. § 314.50 among the forms that constitute a "petition"

Section 10.85 - Advisory opinions

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 314.430 - Availability for public disclosure of data and information in an application or abbreviated application

Section 314.93 - Petition to request a change from a listed drug

Allowing ANDA applicants to submit an abbreviated new drug application for a drug product not identical to the listed drug "in route of administration, dosage form, and strength, or in which one active ingredient is substituted for one of the active ingredients" upon the permission and approval of the FDA

Section 310.200 - Prescription-exemption procedure

Section 312.42 - Clinical holds and requests for modification

Laying out procedures for hold removal request or appeal of an FDA hold decision

Section 10.3 - Definitions

Defining administrative record for FDA decisions

Section 1040.20 - Sunlamp products and ultraviolet lamps intended for use in sunlamp products

Section 10.20 - Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure