Law360, New York (July 17, 2012, 2:30 PM EDT) -- Meredith Manning is a partner in Hogan Lovells LLP's Washington, D.C., office, where she co-chairs the firm's pharmaceutical and biotechnology practice group. She counsels pharmaceutical companies on regulatory standards of the U.S. Food and Drug Administration with respect to the review, approval, and oversight of drug and biological products. She has experience addressing issues surrounding clinical trials, drug and biologic drug approval standards, and FDA compliance. She counsels clients concerning enforcement matters threatened or brought by the FDA and other regulatory bodies, including issues surrounding advertising and promotion of drugs and good manufacturing practices. This includes performing internal investigations, counseling companies about anticipated enforcement, responding to FDA inspectional observations, notices of violations and warning letters, and negotiating consents decrees with the FDA and the U.S. Department of Justice....
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