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Failure to file a medical device report within 30 days and to establish adequate procedures for corrective and preventive actions (CAPAs) were among the quality system deviations the FDA discovered during a March 16 to May 4 inspection of Myerson’s Chicago, Illinois facility. Read More
Failure to validate its products or to establish procedures that demonstrate its acupressure bracelets for nausea were manufactured according to specifications were among the 13 quality system lapses observed during a March 29 to April 1 FDA inspection of MumEase’s Charlotte, North Carolina facility. Read More
The FDA said it was proposing to refuse Intarcia Therapeutics’ drug-device combination product, ITCA 650, for continuous release of the type II diabetes drug exanatide. Read More
Heather Bresch — daughter of U.S. Sen. Joe Manchin (D-W.V.) and former CEO of Mylan — allegedly played a key role in squelching both a competing epinephrine self-injector and single-dose EpiPens, leaving pricey two-dose brand-name packs as patients’ only options, newly released court documents are claiming. Read More
Abbott Laboratories’ CardioMEMS implantable heart failure monitor missed the primary endpoint in an expanded patient population, but the company said that COVID-19 may have skewed the results. Read More
The FDA is getting back its rulemaking authority, which was significantly weakened under President Trump, as the Biden administration reverses multiple policies from the previous administration. Read More
The FDA issued an update on which types of devices may be offered as over the counter (OTC) devices and what devicemakers should consider when making the switch from prescription to OTC status. Read More
Australia’s Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) urged regulators to consider taking a risk-based approach to the use of artificial intelligence (AI) in the pharmaceutical industry in a new report. Read More