Healthcare industry stakeholders say the FDA should consider a type of measuring stick when evaluating a vendor’s cybersecurity culture to decide whether it meets the requirements for the agency’s proposed fast-past program for premarket approval of "software as a medical device" products (SaMD). Until the end of the last month, the FDA accepted proposals on its working model for a SaMD pre-approval program
Scott Gottlieb, FDA Commissioner is looking for help from Facebook and Twitter to slow down the unauthorized opioid sales in the US. Gottlieb invited the two social media giants, among others, to participate in the FDA Online Opioid Summit which is set for June 27.
According to the FDA, if the antidote drugs are used on a patient, they could suffer from “allergic reactions, local irritation” and a wide number of cardiovascular issues, including restriction of blood supply to tissues. The FDA stated that there has not yet been any reports of patient harm from Naloxone.
Today the FDA will officially exempt individual genetic risk tests from 501(k) premarket approval with the condition that the company offering the test should have a one-time premarket review of its testing apparatus and at least one test.
In a major setback for Eisai and Merck & Co, the FDA has stalled the roll-out of Lenvima as a treatment for earlier untreated liver cancer patients. Big things were expected by Merck & Co when Eisai’s Lenvima was scheduled to be launched in March. Merck has agreed to shell out USD 5.8 billion on half of the liver cancer’s drug sales.
Aimovig, a ground-breaking drug to prevent Migraines was approved by the FDA last week. Aimovig will be the only player in the market to treat migraines. The new drug has to be taken once a month through an injection similar to an insulin shot or an EpiPen.
A particular proposal regarding displaying drug prices in TV ads flummoxed pharma marketers and ad agencies following the unveiling of the drug-pricing agenda by President Trump. Marketers have been hounded with the whys and hows of the proposal even as the administration remains firm on its implementation.
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