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Defense Strategies › Food and Drug Administration (FDA) › Federal Food Drug and Cosmetic Act (FFDCA)

Venable LLP

Emerging Litigation Over Ultra-Processed Foods: Strategic Considerations for Food and Beverage Companies

Venable LLP on

Manufacturers and distributors of convenience and snack foods may not want to wait until a lawsuit is filed to start building litigation defense strategies against the wave of litigation targeting the accessibility and...more

Oberheiden P.C.

7 Keys to Effective FDA Audit Defense Strategies

Oberheiden P.C. on

U.S. Food and Drug Administration (FDA) audits can uncover violations of the Food, Drug, and Cosmetic Act (FD&C Act) and other federal food and drug laws and regulations. Those violations can lead to administrative, civil, or...more

Oberheiden P.C.

Did You Receive an FDA Warning Letter? Here's What to Do Next

Oberheiden P.C. on

What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more

Oberheiden P.C.

FDA Warning Letter Response Strategies (Step-By-Step)

Oberheiden P.C. on

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more

Haug Partners LLP

Clarifying the Scope of the Parallel Claim Exception to Federal Regulatory Preemption of Medical Devices

Haug Partners LLP on

Medical device manufacturers who seek to dispose of meritless claims at the initial pleading stage have long relied upon the doctrine of federal regulatory preemption. This doctrine is embodied by 21 U.S.C. § 360k(a), the...more

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