Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA seeks osteoporosis trial design comments

Executive Summary

FDA is seeking comments to modify 11994 draft guidance on osteoporosis clinical trial design. FDA's 2notice asks "do fracture endpoint trials need to be three years in duration, or could shorter studies provide adequate evidence of a new osteoporosis drug's effectiveness and safety?" and "is it appropriate to use placebo controls in fracture endpoint trials?" An advisory committee generally agreed that such studies could be conducted ethically among low-risk patients (3"The Pink Sheet" Sept. 30, 2002, p. 17)...

You may also be interested in...

Osteoporosis Primary Endpoint Should Remain Fracture Reduction

FDA's revised osteoporosis drug guidance should use fracture reduction as a primary endpoint, while increases in bone mineral density should remain a surrogate endpoint, FDA's Endocrinologic & Metabolic Drugs Advisory Committee said Sept. 25

ICMAD Rebrands As Independent Beauty Association Ahead Of Annual FDA Regulations Workshop

IBA’s name change refines its identity as the representative of the independent and entrepreneurial beauty industry, according to the trade organization’s announcement. The group’s FDA Cosmetics Regulation Workshop, held annually since 1983 in cooperation with the FDA, will be virtual in 2020.

Ruth Bader Ginsburg’s Impact On Pharma, From Patents To The First Amendment

Justice Ginsburg wrote two decisions in pharmaceutical related-cases over the past decade, joined the majority in opinions on the scope of patents, and dissented in decisions giving protection to generic manufacturers and speech of pharmaceutical companies. Her death could impact the outcome of cases challenging the Affordable Care Act.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts