- Gottlieb Proposes Modernization of Drug Review Office (biopharminternational.com)
...FDA Commissioner Scott Gottlieb, MD, announced that the Center for Drug Evaluation and Research would be taking steps to modernize the organization and functions of the Office of New Drugs in order to address scientific and medical advances within the industry. The goal is to make the review process more integrated across science and regulatory expertise. Janet Woodcock, director of CDER, plans on elevating the role of FDA scientists and medical officers and providing these officers with more tools and support “to advance the clinical and regulatory principles that the FDA uses to evaluate new drugs for safety and efficacy.”...Other changes will include the development of guidance documents, giving review staff more time with sponsors, and getting sponsors involved earlier in the development process. Engaging disease specialists, academic researchers, regulatory partners at other agencies, and patient groups is also a goal of CDER.
- 6 Must-Know Facts About Cryotherapy (pharmacytimes.com)
Touted as a way to reduce pain, speed injury recovery, and improve mood, cryotherapy involves exposing the body to temperatures up to minus 300 degrees Fahrenheit…Celebrities and some athletes…are proponents of this treatment. However, a recent death has called the safety and efficacy of cryotherapy into question…Chelsea Ake-Salvacion who worked at a Las Vegas cryotherapy center called Rejuvenice died during an after-hours session in a tank, where she was alone...found “rock-hard solid.”…The coroner’s office determined that Ake-Salvacion died from asphyxia from an oxygen-poor environment…Cryotherapy environments can have oxygen levels around 5%—so low that someone can fall unconscious and die…Here are 6 must-know facts about cryotherapy:
- There are 2 ways to experience whole-body cryotherapy.
- One study did find some evidence that whole-body cryotherapy can reduce inflammation.
- Another study shot down cryotherapy as a successful treatment for repairing muscle damage or reducing soreness.
- Cold baths and packs may be the way to go until further research is completed.
- Cryotherapy is not regulated.
- Ake-Salvacion is not the only one harmed by cryotherapy.
- Getting Ahead with Modafinil: Is the Hottest New Smart Drug Safe? (mensjournal.com)
..latest wonder drug to make headlines sounds like a dream for ambitious workers: Modafinil, a narcolepsy pill, has been shown to make you a sharper thinker, a better decision maker, and generally more alert – whether or not you have a sleep disorder, researchers found few safety concerns or side effects from the drug…main problem…no long-term studies of safety and efficacy in healthy people,..Without safety studies,. .."we do not know that modafinil is safe in the long-term for people to use."