QMSR: The Future of FDA's Quality Management ...

Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), ...  Show more

Many early-stage medical device founders face a major dilemma: how do you prove regulatory maturity to investors and partners before you actually hold a final CE mark or FDA approval? Waiting until the end of a long development cycle creates significant commercial risk. By treati ...  Show more

Rules for the regulation of medical devices, such as hip prostheses and implantable defibrillators, are complex and differ from those for drugs. Aaron Kesselheim, MD, JD, MPH, and Jonathan Darrow, SJD, LLM, JD, MBA, both faculty members in the Division of Pharmacoepidemiology ...

Send a message to the show!The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? U ...  Show more

In this episode, Dr. Aaron Carroll talks with Hugh Lee, associate professor of biomedical engineering and director of the Center for Implantable Devices at Purdue University. They discuss how research translates into new implantable medical devices, including a device Lee is work ...  Show more

Send a message to the show!Managing antimicrobial resistance (AMR) will require innovative solutions from many different disciplines. Could pharmacovigilance be one of them? Jean Marie Vianney Habarugira and Albert Figueras, who have been investigating how drug safety tools could ...  Show more