Celotex Corp. v. Catrett

Holding that a movant's summary judgment motion should be granted "against a [nonmovant] who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial"

Matsushita Elec. Indus. Co. v. Zenith Radio

Holding that, on summary judgment, antitrust plaintiffs "must show that the inference of conspiracy is reasonable in light of the competing inferences of independent action or collusive action that could not have harmed" them

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"

Wyeth v. Levine

Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

Riegel v. Medtronic, Inc.

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

Buckman Co. v. Plaintiffs' Legal Committee

Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA

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”

Fla. Avocado Growers v. Paul

Holding federal regulation concerning maturity of avocados did not preempt California regulation, where it was not impossible for growers to comply with both regulations

Capital Cities Cable, Inc. v. Crisp

Holding ban pre-empted by Federal Communications Commission regulations

City of New York v. Federal Communications Commission

Finding that the FCC's adoption of "regulations that establish technical standards to govern the quality of cable television signals" pre-empted local signal quality standards

Rule 56 - Summary Judgment

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

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 331 - Prohibited acts

Prohibiting the sale of adulterated foods

Section 321 - Definitions; generally

Defining “new drug”

Section 352 - Misbranded drugs and devices

Setting labeling requirements for drug products

Section 337 - Proceedings in name of United States; provision as to subpoenas

Restricting FDCA enforcement to suits by the United States

Section 333 - Penalties

Defining civil and criminal penalties for violations of Section 331

Section 334 - Seizure

Authorizing a libel for condemnation of adulterated and misbranded pharmaceuticals

Section 332 - Injunction proceedings

Granting the district court jurisdiction to restrain violations of FDCA

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 314.3 - Definitions

Defining "reference listed drug"

Section 314.80 - Postmarketing reporting of adverse drug experiences

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

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 201.80 - Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in Section 201.56(b)(1)

Requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”

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

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