Professional Pharmaceutical Legal Services in Los Angeles, CA
Mohajerian provides legal advice to pharmaceutical, biotechnology, and medical device companies on matters at the intersection of FDA regulation and intellectual property. Mohajerian has extensive experience in advising companies on market protection strategies and data exclusivity. The firm works with the FDA’s Center for Drug Evaluation and Research (CDER). The center evaluates new drugs before they are allowed to be sold. CDER’s evaluation provides doctors and patients the information they need to use medicines correctly. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks. Drug companies (“Applicant”) seeking to sell a drug in the US must first test it. The Applicant sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. It is best to use competent counsel to communication with the CDER. CDER’s physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s report, data and proposed labeling. If the review establishes that a drug’s health benefits outweigh its known risks, the drug is then approved for sale in US.