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

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

Medtronic, Inc. v. Lohr

Holding that the presence of a state-law damages remedy for violations of FDA requirements does not impose an additional requirement upon medical device manufacturers but "merely provides another reason for manufacturers to comply with . . . federal law"

Auer v. Robbins

Holding that a federal agency's interpretation of a regulation is controlling where it is not "plainly erroneous or inconsistent with the regulation"

Riegel v. Medtronic, Inc.

Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

English v. General Electric Co.

Holding that a tort arising from whistleblower retaliation at a nuclear facility was insufficiently related to radiological safety aspects in the facility's operation

Fidelity Federal Savings & Loan Ass'n v. De La Cuesta

Holding that a regulation authorizing federal savings-and-loan associations to include due-on-sale clauses in mortgage contracts conflicted with a state-court doctrine that such clauses were un-enforceable

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”

Hillsborough County v. Automated Medical Labs

Holding local health ordinance not preempted because "the regulation of health and safety matters is primarily, and historically, a matter of local concern"

Perez v. Campbell

Holding that federal bankruptcy law preempted a state law that interfered with federal bankruptcy law's goal of providing uniform standards for determining discharge of debt

Sprietsma v. Mercury Marine

Holding that the Coast Guard's decision not to regulate propeller guards did not impliedly pre-empt petitioner's tort claims

Section 301 - Short title

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 352 - Misbranded drugs and devices

Setting labeling requirements for drug products

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 201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in Section 201.56(b)(1)

Listing requirements for different subsections for indications, dosage, and clinical studies

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 314.80 - Postmarketing reporting of adverse drug experiences

Requiring report of “serious and unexpected” adverse event within 15 days

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 201.56 - Requirements on content and format of labeling for human prescription drug and biological products

Disallowing claims or suggestions of drug use on labeling if there is a lack of substantial evidence