40 Cited authorities

Chevron U.S.A. v. Natural Res. Def. Council
467 U.S. 837 (1984) Cited 16,017 times 502 Legal Analyses
Holding that courts "must give effect to the unambiguously expressed intent of Congress"
Motor Vehicle Manufacturers Assoc. of the United States, Inc. v. State Farm Mutual Auto. Ins. Co.
463 U.S. 29 (1983) Cited 6,630 times 50 Legal Analyses
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]'"
TRW Inc. v. Andrews
534 U.S. 19 (2001) Cited 1,185 times 9 Legal Analyses
Holding a cardinal principal of statutory interpretation is that “no clause, sentence, or word shall be superfluous, void, or insignificant”
Encino Motorcars, LLC v. Navarro
136 S. Ct. 2117 (2016) Cited 371 times 18 Legal Analyses
Holding that agency needed to provide "a more reasoned explanation for its decision to depart from its existing ... policy" in light of serious and ongoing industry reliance on prior policy when negotiating compensation packages
Securities Comm'n v. Chenery Corp.
332 U.S. 194 (1947) Cited 4,141 times 14 Legal Analyses
Holding that reviewing court may consider only grounds invoked by agency
Christopher v. Smithkline Beecham Corp.
567 U.S. 142 (2012) Cited 332 times 4 Legal Analyses
Holding that Auer "[d]eference is undoubtedly inappropriate. . . when the agency's interpretation is plainly erroneous or inconsistent with the regulation."
Martin v. Oshrc
499 U.S. 144 (1991) Cited 598 times 4 Legal Analyses
Holding that a reviewing court should defer to the Secretary of Labor when the Secretary and the Commission provide reasonable but conflicting interpretations of an ambiguous regulation promulgated under the Occupational Safety and Health Act
Long Island Care at Home v. Coke
551 U.S. 158 (2007) Cited 332 times 22 Legal Analyses
Holding authorization for Secretary of Labor to "prescribe necessary rules, regulations, and orders" provided the Department of Labor "with the power to fill [explicit statutory] gaps"
Nat'l Labor Relations Bd. v. Wyman-Gordon Co.
394 U.S. 759 (1969) Cited 799 times 3 Legal Analyses
Holding invalid a legislative rule developed in agency adjudication
Tcherepnin v. Knight
389 U.S. 332 (1967) Cited 702 times 5 Legal Analyses
Holding withdrawable capital shares in savings and loan association a security
Section 706 - Scope of review
5 U.S.C. § 706 Cited 20,437 times 184 Legal Analyses
Granting courts jurisdiction to "compel agency action unlawfully held or unreasonably delayed"
Section 271 - Infringement of patent
35 U.S.C. § 271 Cited 6,039 times 1049 Legal Analyses
Holding that testing is a "use"
Section 355 - New drugs
21 U.S.C. § 355 Cited 2,244 times 337 Legal Analyses
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 351 - Adulterated drugs and devices
21 U.S.C. § 351 Cited 340 times 32 Legal Analyses
Referencing the U.S. Pharmacopeia's strength, quality, and purity standards
Section 314.101 - Filing an NDA and receiving an ANDA
21 C.F.R. § 314.101 Cited 31 times 9 Legal Analyses
Providing that an "NDA may be filed" once the "FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review"

Amneal Pharmaceuticals Llc v. Food And Drug Administration et al

40 Cited authorities

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

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]'"

Holding a cardinal principal of statutory interpretation is that “no clause, sentence, or word shall be superfluous, void, or insignificant”

Holding that agency needed to provide "a more reasoned explanation for its decision to depart from its existing ... policy" in light of serious and ongoing industry reliance on prior policy when negotiating compensation packages

Holding that reviewing court may consider only grounds invoked by agency

Holding that Auer "[d]eference is undoubtedly inappropriate. . . when the agency's interpretation is plainly erroneous or inconsistent with the regulation."

Holding that a reviewing court should defer to the Secretary of Labor when the Secretary and the Commission provide reasonable but conflicting interpretations of an ambiguous regulation promulgated under the Occupational Safety and Health Act

Holding authorization for Secretary of Labor to "prescribe necessary rules, regulations, and orders" provided the Department of Labor "with the power to fill [explicit statutory] gaps"

Holding invalid a legislative rule developed in agency adjudication

Holding withdrawable capital shares in savings and loan association a security

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

Holding that testing is a "use"

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"

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

Providing that an "NDA may be filed" once the "FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review"