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FDA Pharmaceuticals Compliance

How to Register Pharmaceutical Products with the FDA

Ms. Capote is an FDA Lawyer in Florida.  She helps businesses register their pharmaceutical products with the FDA and also assists with all FDA matters related to compliance.

The United States Food and Drug Administration (FDA) and the FDA’s Center for Drug Evaluation and Research (CDER) monitors pharmaceutical companies who must comply with specific FDA rules and regulations while selling prescription medications in the United States. The FDA prohibits false marketing of medications to the public within the United States and their advertisements must not be adulterated, misbranded, or mislabeled in any manner.

Laboratory research and the actual development of prescription drugs can be a complex process in itself. Capote Law Firm FDA compliance lawyers are available throughout the process to provide legal advice to clients during the FDA approval process. Our prescription drug attorneys assist clients with determining if they need an Investigational New Drug Application (IND) and facilitate pre-IND meetings with FDA officials.

FDA registration for pharmaceuticalsOnce the FDA approves a new pharmaceutical drug, it still needs prescription drug post-approval oversight. Capote Law Firm prescription medicine attorneys can help establish a compliance program and defend your corporation against potential enforcement actions. Our FDA compliant lawyers advise on FDA regulations involving Direct-to-Consumer Advertising (DTCA); DDMAC submissions; Application Integrity Policy (AIP).; APLS; MedWatch program compliance; Standard Operating Procedures (SOPs); and Vaccine Adverse Event Reporting System (VAERS). Together, our legal staff and your corporation can ensure your new pharmaceutical products are ready to be marketed by meeting all the reported requirements, safety alerts, and enforcement proceedings including Dear Doctor letters and Black-Box warnings, among others filed by FDA after a prescription drug has been approved.

Capote Law Firm consults with potential clients not only seeking to market pharmaceuticals within the U.S. prescription drug market, but also advice on most FDA compliant matters. Our FDA attorneys assist clients navigate drug recalls; FDA Notice of Action; FDA Enforcement Action Notice; understanding FDA rules and regulations imposed by the Federal Trade Commission (FTC) regarding advertising and marketing of pharmaceuticals; and Customs and Border Protection (CBP).

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