The inject is developed to achieve the natural outflow of aqueous humor by making two patent bypasses through the trabecular meshwork, glaucomatous eyes the main source of resistance resulting in multi-directional flow through Schlemm’s canal
The U.S. healthcare system and the FDA have been affected by manufacturing issues at one of the largest U.S. drugmakers, Pfizer. The company’s Hospira unit is the largest producer of injectable opioid analgesics used in hospitals.
The Food and Drug Administration (FDA) has granted approval for a request made by DreaMed regarding their artificial intelligence-enabled diabetic software, which is exclusively meant for the providers, who are managing Type 1 diabetes patients.
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.
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