Parexel International Corp.
Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From Parexel International Corp.
For drug sponsors, FDA's revised process could mean more public disclosures about potential safety risks and more regulatory actions to address those risks. CDER seeks to better leverage scientific and regulatory expertise, including in product quality and compliance, in investigating safety signals under the new policy manual, which also includes target timelines for action.
Teva has announced a leadership change in its global operations, while Lupin has made a key appointment to focus on quality and compliance. Among other changes in leadership roles, Olainfarm has seen one of its six management board members resign.
Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.
Regulators, industry executives, and patient advocates are losing sleep due to a host of concerns and anxieties, including the need for evolving regulatory paradigms, patients’ ability to access life-changing medicines, and the pace of digital change.