Tag Archives: FDA

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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FDA, Drug Companies Struggle with Compassionate Use Requests

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval. As 7-year-old cancer patient Josh Hardy gained relief from a life-threatening infection following a bone marrow transplant thanks to […]
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FDA Wants YOU!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and Center leaders are looking for experienced industry managers to help rebuild its staff. Many experienced FDAers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment” of the agency, […]
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