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

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

Mathews v. Eldridge

Holding that a procedure based on written submissions was adequate because it included safeguards against mistake including that the agency informed the recipient of its tentative assessment and the evidence supporting it and an opportunity was then afforded the recipient to submit additional evidence "enabling him to challenge directly the accuracy of information in his file as well as the correctness of the agency's tentative conclusions"

Motor Vehicle Manufacturers Assoc. of the United States, Inc. v. State Farm Mutual Auto. Ins. Co.

Holding that " `settled course of behavior embodies the agency's informed judgment that, by pursuing that course, it will carry out the policies [of applicable statutes or regulations]'"

United States v. Mead Corp.

Holding that a Customs classification ruling "has no claim to judicial deference under Chevron " but can "claim respect according to its persuasiveness"

Bowen v. City of New York

Holding claims collateral because plaintiffs "neither sought nor were awarded benefits ... but rather challenged the Secretary’s failure to follow the application regulations"

Barnhart v. Walton

Holding that the “‘ 12 month' duration requirements apply to both the ‘impairment' and the ‘inability' to work requirements”

Robinson v. Shell Oil Co.

Holding that the term “employees” carries a different meaning in different sections of Title VII

Citizens to Preserve Overton Park v. Volpe

Holding a decision is committed to agency discretion when there is "no law to apply"

United Savings Assn. v. Timbers of Inwood Forest

Holding that § 506(b) “deni [es] ... postpetition interest to undersecured creditors,” and recognizing “an apparent anomaly” that when a debtor proves solvent, 11 U.S.C. § 726 provides for post-petition interest on unsecured claims “but not on the secured portion of undersecured creditors' claims,” but concluding that these particular “inequitable effects ... are entirely avoidable, since an undersecured creditor is entitled to ‘surrender or waive his security and prove his entire claim as an unsecured one’ ”

Fuentes v. Shevin

Holding that disputed possessory interest in personal property is a protected property interest

Rule 56 - Summary Judgment

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

Section 706 - Scope of review

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

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 351 - Adulterated drugs and devices

Referencing the U.S. Pharmacopeia's strength, quality, and purity standards

Section 314.94 - Content and format of an ANDA

Explaining that products stemming from Drug Efficacy Study Implementation approvals are subject to today's ANDA regulations

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 314.105 - Approval of an NDA and an ANDA

Explaining that a "tentative" approval is the same as a final approval with a delayed effective date

Section 314.150 - Withdrawal of approval of an application or abbreviated application

Requiring products to be withdrawn from the market where the FDA revokes approval

Section 314.127 - Refusal to approve an ANDA

Listing reasons the FDA will refuse approval of an ANDA, none of which concern patent litigation under § 271(e)

Section 314.110 - Complete response letter to the applicant

Describing FDA process for complete response letters

Section 314.200 - Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing

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