The FDA has issued final guidance clarifying what it considers permissible off-label information for devicemakers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the agency […]
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 seeks to bring clarity to combination product regulation
The FDA proposed a rule today that would amend regulations regarding the classification of products as biological products, devices, drugs or combination products. The agency said it hopes to modernize the regulations that surround the classification and assignment of medical products to individual centers for review – including drug-device combination products. Get the full story […]
FDA chief suggests kickback laws 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. […]
Is FDA’s easing of medical device malfunctioning reporting a good thing?
The news came out in 2016 that medical device companies were late filing more than 300,000 adverse events reports to U.S. FDA. “I think that’s simply embarrassing as an industry,” regulatory consultant Mike Drues said during his latest podcast with Medical Design & Outsourcing. FDA’s solution has partly been to propose an easing of the reporting requirements. […]
FDA issues draft guidance for the use of diagnostics in cancer drug trials
The FDA issued draft guidance this week describing a streamlined submission process to determine whether using an in vitro diagnostic in a cancer drug’s clinical trial poses a significant or nonsignificant risk. The agency wrote that sponsor should use the proposed pathway when possible “to reduce administrative burden on sponsors and FDA and to maintain […]
Report: FDA guidance ‘fraught with potential complications’ for drug-device products
The FDA issued revised guidance documents earlier this year clarifying the agency’s ‘Refuse to Accept’ policy for 510(k)s and PMAs. The updated policy raises questions for companies developing and submitting combination products for regulatory approval, according to lawyers Allyson Mullen and Rachael Hunt. The associate partners detailed changes to the components that companies must include […]
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