The FDA today warned doctors and patients about the serious complications that can occur when using the wrong painkillers with implantable drug pumps. Dosing errors, pump failure, and infection are just some of the potential problems that can crop up when using drugs that aren’t approved for use with particular devices, the regulatory agency said. […]
FDA
FDA proposes global harmonization of standards for generic drug developers
The FDA has proposed that the International Council on Harmonisation set global standards for generic drug developers, according to a report from FDA chief Dr. Scott Gottlieb. The U.S. regulatory agency argued that companies making generic drugs should be able to implement a single global drug development program and file for approval across multiple markets […]
Cook, AcuityBio ink deal for lung cancer drug technology
Cook Biotech will collaborate with drug-delivery maker AcuityBio on Acuity’s lead lung cancer product, the companies said today. Acuity’s ABC103 will use Cook Biotech’s proprietary extracellular matrix (ECM) technology. ABC103 is a platform technology designed for localized, sustained drug delivery to prevent post-surgical lung cancer recurrence. It combines approved/ cleared surgical staple-line buttress, drug-eluting polymers and […]
Kala Pharma wins FDA nod for twice-daily ocular corticosteroid
The FDA has approved Kala Pharmaceuticals’ (NASDAQ:KALA) Inveltys to treat post-operative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication, according to the Waltham, Mass. company. While corticosteroids are used following ocular surgery to control inflammation and pain, physicians prescribe ocular steroids to achieve a rapid […]
FDA’s Gottlieb: Drug shortages are an ‘inevitable consequence of an imperfect system’
When doctors and nurses are faced with a shortage of medically necessary drugs, they are forced to make challenging decisions about how to ration whatever they have left. FDA commissioner Dr. Scott Gottlieb is looking to identify ways that the U.S. regulatory agency can help prevent and predict these shortages. In a statement this week, […]
FDA launches medical device innovation challenge to combat opioid crisis
The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go […]
Report: Trump to sign controversial law granting patients access to experimental drugs
President Donald Trump is slated to approve legislation this week that will give terminally-ill patients access to experimental drugs that haven’t yet been cleared by the FDA. The “right-to-try” bill has sparked a great deal of controversy among policymakers and patient groups. While some, including the president, describe the effort as offering hope to patients […]
Here are the pharma companies accused of blocking generic competition
To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer. But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could […]
FDA approves first non-opioid treatment for opioid withdrawal symptoms
The FDA today approved the first non-opioid treatment designed to help manage the symptoms of opioid withdrawal in adults. The drug, Lucemyra, isn’t a treatment for opioid use disorder, the agency noted. Instead, it is meant to be used as part of a broader plan to help adults manage their symptoms when they stop using […]
FDA chief suggests kickback law could be used to rein in drug prices
Drug rebates paid between pharmaceutical companies and pharmacy benefit managers enjoy safe harbor status under federal kickback law, leaving them immune from legal scrutiny. But that could change, FDA chief Dr. Scott Gottlieb suggested yesterday at the FDA Law Institute’s annual meeting. The commissioner reportedly hinted that reinterpreting the law could help lower drug prices. […]
