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' "

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

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

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"

Summers v. Earth Island Inst.

Holding that supplementation of the district court record to receive affidavits from the organization's members was not permitted "in the circumstances here: after the trial is over, judgment has been entered, and a notice of appeal has been filed"

Medimmune, Inc. v. GenenTech, Inc.

Holding "the phrase 'case of actual controversy' in the Act refers to the types of 'Cases' and 'Controversies' that are justiciable under Article III"

Bennett v. Spear

Holding that a Final Biological Opinion has "legal consequences," even though the action agency is not legally obligated to accept the opinion's recommendations or conclusions, because the opinion "alter the legal regime to which the action agency is subject"

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

Valley Forge College v. Americans United

Holding that "the psychological consequence presumably produced by observation of conduct with which one disagrees ... is not an injury sufficient to confer standing under Art. III, even though the disagreement is phrased in constitutional terms"

Lewis v. Continental Bank Corp.

Holding mootness destroys subject-matter jurisdiction

Whitmore v. Arkansas

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"

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

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 2201 - Creation of remedy

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

Section 1346 - United States as defendant

Determining liability to the claimant "in accordance with the law of the place where the act or omission occurred"

Section 706 - Scope of review

Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"

Section 701 - Application; definitions

Adopting the definition given in Section 551

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 321 - Definitions; generally

Defining “new drug”

Section 343 - Misbranded food

Setting labeling requirements for food products

Section 334 - Seizure

Authorizing a libel for condemnation of adulterated and misbranded pharmaceuticals

Section 10.30 - Citizen petition

Describing the requirements for filing a citizens' petition

Section 101.9 - Nutrition labeling of food

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

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 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 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 170.3 - Definitions

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)

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."