Articles by Angie Drakulich - BioPharm International

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Articles by Angie Drakulich

CDER Identifies Key Regulatory Science Needs and Strategies

Aug 2, 2011

FDA released this week a report from its Center for Drug Evaluation and Research (CDER) that identifies regulatory science needs that will guide CDER?s strategic planning in the years ahead and allow it to fulfill its regulatory mission. The report, Identifying CDER?s Science and Research Needs, discusses internal research initiatives and goals for contributing to the agency?s overall regulatory science efforts.

FDA Introduces Strategy to Combat Food Smuggling

Jul 19, 2011

In early July 2011, FDA provided an update in which the agency said that it has made progress toward implementing the US Food Safety Modernization Act (FSMA), which was enacted in January 2011. In addition to clarifying expectations for new dietary ingredients through new draft guidance, the agency has issued an antismuggling strategy.

Biotech and Emerging Markets: Report from BIO 2011

Jul 5, 2011

At last week?s 2011 Partnering for Global Health Forum, sponsored by the Biotechnology Industry Organization and BioVentures for Global Health, a unique panel of government leaders from emerging markets discussed what it takes to do business in their countries.

FDA Office of Compliance to Become a Super Office

Jun 14, 2011

The FDA Center for Drug Evaluation and Research's Office of Compliance is undergoing some major structural reorganization, according to an internal letter to the CDER staff from Director Janet Wookcock, dated May 26, 2011, which was shared with Pharmaceutical Technology by the agency press office. Specifically, the Office of Compliance will be elevated to a "Super Office." Similar offices exist within CDER including the Office of Pharmaceutical Science. The change means that the Office of Compliance will house subordinate offices, including four new offices, three of which are similar to existing divisions, according to the letter. The new fourth office will be called the Office of Drug Security, Integrity & Recalls (ODSIR) and will focus on addressing the challenges of globalization and an increasingly complex drug supply chain. This includes dealing with supply-chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls, according to the announcement.

FDA Approvals of Biopharmaceuticals on the Rise

May 24, 2011

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, according to a new report from the Tufts Center for the Study of Drug Development, based in Boston. There are, however, substantial challenges ahead for biopharmaceutical manufacturers if they wish to maintain that pace, said Janice Reichert, PhD, research assistant professor at Tufts University and author of the study, in a press release about the report.

FDA to Study Online Drug Marketing

May 10, 2011

FDA is collecting public comments on a series of studies that the agency plans to conduct on online direct-to-consumer (DTC) promotion of prescription drug products, according to an announcement in the Apr. 28, 2011, Federal Register.

PDUFA Discussions Continue, New Review Models Proposed

Dec 9, 2010

The US Food and Drug Administration posted on its website the minutes of the latest meetings between the agency and industry, and among stakeholders, regarding the reauthorization of the Prescription Drug User Fee Act V. The meetings were held Nov 17-18.

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