regulatory Archives - Medical Design Sourcing

FDA efforts to prioritize medtech innovation pay dividends

From left to right: Kwame Ulmer, Jennifer McCaney and DeviceTalks West moderator Tom Salemi discuss medtech innovation. [Photo by Brian Buntz/Medical Design & Outsourcing]

A decade ago, medical device companies often turned to Europe to score initial regulatory approval for new products. Even though the U.S. is a larger market, many companies looked to Europe to win regulatory approval for their medtech innovation efforts. As a result, European patients received access to new therapies an average of two years earlier than U.S. patients, according to 2010 research from Dr. Josh Makower.

But now the tables have turned, and the FDA is more likely to approve or clear novel medical devices before their European counterparts.

“Where we were 10 years ago is not where we are today,” said Jennifer McCaney, the executive director of UCLA Biodesign at DeviceTalks West.

McCaney collaborated wi…

Why emergency authorization of COVID-19 therapies could pose regulatory questions

Image by Arek Socha from Pixabay

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

Get the full…

Why emergency authorization of COVID-19 therapies could pose regulatory questions

Image by Arek Socha from Pixabay

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

Get the full story from our sister site, Drug Discovery & Development.

Why emergency authorization of COVID-19 therapies could pose thorny regulatory questions

Image by Arek Socha from Pixabay

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

Further compl…