The U.S. FDA’s effort to marry its quality systems regulations with ISO 13485 has hardly gone off without a hitch, but Melissa Torres, director of international programs at the FDA’s device center, said the agency is “very hopeful” it can publish a draft rule for that task by the end of this year.
DUBLIN—Can high-dose inhaled nitric oxide (NO) make a meaningful contribution to patients with COVID-19 infection? The FDA was sufficiently persuaded by the data presented by Bellerophon Therapeutics Inc. to grant it expanded access approval for its iNOpulse system for pulmonary delivery of NO.
The U.S. FDA is well known for encouraging industry to meet with the agency “early and often” for complex premarket filings, but the Combination Products Coalition (CPC) says a recent draft guidance seems to offer the exception. The group said the December 2019 FDA guidance for feedback on combination product applications “seems to generally discourage” the use of the combination product agreement meeting (CPAM). It added that the complexity of some combination products suggests that such a meeting may well be crucial to an efficient application process.
Touting the efforts his administration already has taken to lower U.S. prescription drug prices through increased competition, President Donald Trump placed the burden for further action squarely on Congress during his State of the Union address Tuesday, Feb. 4.
Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics.
The controversy over the use of paclitaxel-bearing devices in the femoropopliteal arteries is far from over. Now, a new medical journal article makes a similar claim about mortality in connection with the use of these devices in the infrapopliteal arteries, threatening once again to take a bite out of utilization.
The controversy over paclitaxel (PCT)-associated mortality in devices for the peripheral arteries is far from over, but another medical journal article has punched a hole in the credibility of the paclitaxel theory with the conclusion that the evidence is unequivocal and may be unpersuasive to physicians.
With many on Wall Street transfixed by the three injectable calcitonin gene-related peptide (CGRP) therapies cleared in the prophylactic migraine market, Satsuma Pharmaceuticals Inc.’s prospects with STS-101 may have gone overlooked, at least until lately.
Drug addiction has often proven resistant to the best efforts for treatment. New York-based startup Medicasafe Inc. hopes to provide another tool in the arsenal to boost opioid use disorder (OUD) treatment. Rather than send a recovering addict home every couple of weeks with an unmonitored and uncontrolled supply of buprenorphine and naloxone, it has developed a drug-device combination product that digitally enables and tracks patient retrieval of these drugs.
LONDON – There is no evidence for increased mortality in patients receiving paclitaxel-eluting stents and drug-coated balloons (DCBs) to treat peripheral arterial disease, according to the largest real-world safety analysis to date. The findings may come as a relief to many, particularly after a meta-analysis published in December 2018 led to safety warnings and restrictions on the use of coated and drug-eluting devices.