This week we had 70 degree temperatures and predictions of snow. It seems we are living in roller coaster times – at least for this month. For all the lovers out there, hope the Valentine’s Day was second to none. Here is a bit of what happened in our world this week.
- Artificial Intelligence (AI) and Stroke – It is said that speed is everything in the wake of a stroke. This week FDA permitted the marketing of clinical decision support software that can alert providers when a stroke may have occurred with a patient. The software analyzes computed tomography results for indicators that a patient may have experienced a stroke and sends a notification to a neurovascular specialist if circumstances indicate a large vessel blockage. The application, which was approved through the De Novo premarket review pathway for new types of devices deemed low to moderate risk and have no legally marketed predicate device as an equivalent, is limited to analyzing data and not intended to be a replacement for a full patient evaluation or relied on solely to make a diagnosis.
- Multiple Guidance Docs on Drug Development – This week FDA issued an extraordinary number of guidance and draft guidance documents related to the development of range of drugs related to neurological conditions. This included guidance for Duchenne Muscular Dystrophy, ALS, Early Alzheimer’s, Migraine, and Partial Onset of Seizures. The issuance of the guidance documents was accompanied by a lengthy statement from the Commissioner that said emphasized the need to modernize drug regulatory programs in the face of the urgent need in these areas. The term “modernize” appears to be emerging as code for removing regulatory hurdles. One of the aspects in modernizing is to speed up the guidance development process – one that has actually often taken years (as we learned on the social media front). On this front, he stated that more guidance documents would be forthcoming noting pointedly one for treatments for opioid dependence and addiction. He also assured that the changes made will also nevertheless maintain scientific integrity in addressing safety and efficacy. You can read an overview this development here at the RAPS site.
- Gottlieb Speech on Opioids– Dr. Gottlieb delivered remarks at a public workshop on Strategies for Promoting the Safe Use and Appropriate Prescribing of Prescription Opioids. Comparing the opioid abuse epidemic to a pathogen, he concentrated on providing a concise overview of many of the steps FDA has taken to curb addiction. In addition, he said that FDA was taking a look at the use of gabapentinoids and the off-label prescribing patterns to use this FDA-approved medication as an alternative to opioids and stated that while increased use is not yet perceived as an issue, the agency was looking to see if there was an abuse/misuse problem emerging. In combination with actions taken against other non-opioid compounds in the past weeks, it is demonstrative of FDA’s approach encompassing addressing aspects of the problem from the edges.
Upcoming Events to Keep an Eye on This Week
- February 22-23 – FDA – AACR- Astro Workshop – Clinical Development of Drug-Radiotherapy Combinations
Regulatory Developments in Pharma/Biotech/Devices
- Filing for Fabry Disease Treatment Accepted with Priority Review
- sNDA Accepted for Anaphylaxis Accepted by FDA
- Generic Injectable MS Treatment Approved and Launched
- Breakthrough Therapy Given to Investigative Compound for Atopic Dermatitis
- FDA Approves Combination for Cystic Fibrosis
- FDA Approves HPV to Detect and Test to ID Genotypes