Tag Archives: FDA

US Regulators and Industry Bodies Push Forward with Global Expansion

At the annual meeting of the Food and Drug Law Institute (FDLI) this year, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. In addition to conducting more inspections and oversight of […]
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Suffer Little Children? To Medicate or Not to Medicate Toddlers

When Audre McDonald accepted her sixth Tony Award (theater’s version of the Academy Awards) this month in New York City, and broadcast live on national television, she thanked her parents “for their unwillingness to put her on stimulant medication, which she believed led to her stunning success in musical theater.” In the aftermath, her comments […]
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Margaret Hamburg Addresses Biopharma’s Pressing Issues

Speaking at the 2014 New York BIO conference, FDA Commissioner, Dr. Margaret Hamburg, addressed the pressing issues affecting the biopharmaceutical industry and the FDA. Applied Clinical Trials’ Moe Alsumidaie relays Dr Hamburg’s the highlights of Dr. Hamburg’s presentation below.
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FDA Targets Online Pharmacies

By Melanie Sena, Pharmaceutical Technology. FDA, in partnership with other federal and international agencies, has  taken action against websites that sell potentially dangerous, unapproved prescription drugs to US consumers. FDA and the US Customs and Border Protection (CBP) also conducted examinations at US-based international mail facilities, where many packages containing prescription drugs enter the US, […]
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FDA Takes First Amendment Issues "Seriously"

Several legal cases have challenged the Food and Drug Administration’s approach to regulating industry communications about medical products, and agency officials now are acknowledging the importance of addressing these developments head-on. In the wake of U.S. v. Caronia and IMS v. Sorrell, the spotlight is on speech-related activity, including product labeling and advertising and promotion […]
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