Tag: innovation
Drug Import Regulation: On the Brink of Historic Change
On Friday, July 12, 2013, the Food and Drug Administration (FDA) hosted a public meeting to discuss the implementation of the drug supply chain provisions to Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA). The meeting included a host of speakers that shared their perspective on the best course of action for implementation of Section 713 (Standards for Admission of Imported Drugs) and Section 714 (Registration of Commercial Importers of Drugs and Good Importer Practices) of the regulations. The meeting was also open to public comment from industry, trade, and other stakeholders who shared their perspective. Since then, industry groups, drug importers, and other stakeholders have been preparing comments to guide the implementation process. Final comments on the implementation of Sections 713 and 714 are due by August 12, 2013.
The globalization of the drug supply … Read More »
New post from Capitol Health Record on call for more new medicines from Presdient’s Council of Advisors on Science & Technology
Published by Capitol Health Record on October 3, 2012
Written by: Amy Walker
Last week, the President’s Council of Advisors on Science and Technology (PCAST) released their “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.” The report recommends that the United States set a goal of doubling the number of new medicines “that meet critical public health needs” over the next ten to 15 years.
PCAST, which was formed in April 2009 by President Barack Obama, is an advisory group consisting of leading scientists and engineers which makes science and technology policy recommendations to the President and the Executive Office of the President.
For the report, PCAST analyzed trends and challenges in biomedical research and development over recent years, finding that scientists need better methodologies and tools for translating discoveries and pharmaceutical developers and regulators need to incorporate efficiencies … Read More »
U.S. Supreme Court’s Affordable Care Act Decision: Impacts on Life Sciences
The June 28, 2012 U.S. Supreme Court decision upholding the Patient Protection and Affordable Care Act (“Act”) impacts the life sciences industry in a number of ways, including impacts on innovation and compliance initiatives by medical device, pharmaceutical, and biotechnology companies.
Innovation
A number of provisions in the Act provide incentives and resources for product innovation. First, it is expected that more than 30 million Americans will obtain health care coverage on account of the Act. A bigger pool of Americans with health coverage to pay for treatment will yield growth in pharmaceutical sales and, perhaps, the ability to charge higher drug prices, which, in turn, could spur innovation. In addition, the Act created the Therapeutic Discovery Project Program, through which $1 billion in new therapeutic discovery project grants and tax credits will be awarded. In 2010, 2,923 companies specializing in biotechnology … Read More »