Tuft's report backs FDA fast-track, but post-marketing concerns loom

Article Abstract:

A report from the Center for the Study of Drug Development at Tufts University in Boston has indicated that the US Food and Drug Administration's (FDA's) fast-track program has sped drug approvals for agents that fight cancer, HIV/AIDS and rare and orphan diseases. The fast-track biotech drugs might still take a long time to get approval due to their complexity and concerns are increasing that FDA might soon close down on companies failing to complete post-marketing studies for drugs licensed via accelerated approval.

United States, Product development, Government regulation, Licensing, certification and accreditation, United States. Food and Drug Administration, Biopharmaceutics, Biopharmaceuticals

---

Funding crunch forces stem cell company to abandon therapies

Article Abstract:

The Singapore's flagship stem cell company, ES Cell International has shifted its focus from cell-therapy programs to various other stem cell technology developments due to the lack of adequate funds.

Financial management, Management dynamics, Management, Finance, Singapore, Company business management, Company financing, Stem cell research, ES Cell International Private Ltd.

---

Similar abstracts:

• Abstracts: Profiles of research firms. Research (marketing research). Profiles of beauty and fashion PR firms
• Abstracts: Northrop, Raytheon report good profits, but Lockheed comes out ahead. Sugar: awaiting QDR results, Northrop Grumman is 'well positioned'
• Abstracts: Predator and prey. Strategy in the making. Sainsbury: Finding the ingredients for survival
• Abstracts: Hello Kitty Peppermints. Chiclets Fruit Fiesta Sugarless Gum
• Abstracts: Telecoms FDs face uncertain future. Ambition. Give and take

This website is not affiliated with document authors or copyright owners. This page is provided for informational purposes only. Unintentional errors are possible.