Bell Atl. Corp. v. Twombly

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' "

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"

Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.

Holding that plaintiffs who curtailed their recreational activities on a river due to reasonable concerns about the effect of pollutant discharges into that river had standing

Chevron U.S.A. v. Natural Res. Def. Council

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

Lujan v. National Wildlife Federation

Holding the district court did not abuse its discretion in declining to admit affidavits in support of standing when filed after summary judgment briefing and hearing were complete

Pennhurst State School Hosp. v. Halderman

Holding that sovereign immunity prohibits federal courts from "instruct[ing] state officials on how to conform their conduct to state law"

Franchise Tax Bd. v. Laborers Vacation Trust

Holding that a case may not be removed to federal court on the basis of a preemption defense even where "both parties admit that the defense is the only question truly at issue in the case"

Board of Regents v. Roth

Holding that where a public employee's appointment terminated on a particular date and there was no provision for renewal after that date, the employee "did not have a property interest sufficient to require . . . a hearing when [the officials] declined to renew his contract of employment."

Warth v. Seldin

Holding that Article III requires plaintiffs "to establish that, in fact, the asserted injury was the consequence of the defendants' actions"

Cleveland Board of Education v. Loudermill

Holding that the tenured public employee was "entitled to oral or written notice of the charges against him, an explanation of the employer's evidence, and an opportunity to present his side of the story"

Rule 12 - Defenses and Objections: When and How Presented; Motion for Judgment on the Pleadings; Consolidating Motions; Waiving Defenses; Pretrial Hearing

Granting the court discretion to exclude matters outside the pleadings presented to the court in defense of a motion to dismiss

Rule 8 - General Rules of Pleading

Holding that "[e]very defense to a claim for relief in any pleading must be asserted in the responsive pleading. . . ."

Section 1331 - Federal question

Finding that in order to invoke federal question jurisdiction, a plaintiff's claims must arise "under the Constitution, laws, or treaties of the United States."

Section 702 - Right of review

Granting judicial review of "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 353 - Exemptions and consideration for certain drugs, devices, and biological products

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

Section 393 - Food and Drug Administration

Defining the FDA's mission

Section 355c - Research into pediatric uses for drugs and biological products

Section 1.56 - Duty to disclose information material to patentability

Adopting broad standard of materiality requiring that information not be cumulative

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 10.25 - Initiation of administrative proceedings

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

Section 10.45 - Court review of final administrative action; exhaustion of administrative remedies

Providing that " request that the Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a petition submitted under § 10.25 . . . before any legal action is filed in a court complaining of the action or failure to act"

Section 314.125 - Refusal to approve an NDA

Requiring FDA to reject application when proposed labeling is "false or misleading in any particular"

Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

Section 314.71 - Procedures for submission of a supplement to an approved application

Section 310.200 - Prescription-exemption procedure