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Sol-Millennium, one of the three syringe manufacturers called out in a March 19 FDA Safety Communication for potential device failures, says it is “confident” that it can resolve all issues identified in an FDA Warning Letter. Read More
Those who work with laboratory developed tests (LDT) would have much preferred their rapidly developing field be regulated by the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — but since Congress has repeatedly failed to pass the bipartisan act, the field is now reeling at the “overreach” of the FDA’s new proposed rule on regulating LDTs. Read More
In a nod to the increasing potential of demonstrating drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with real-world data (RWD) in mind. Read More
This edition of Quick Notes reviews Becton Dickinson’s increase in U.S. manufacturing of syringes, clearance of the twiist Automated Insulin Delivery system, a new indication for Amplify standalone bone graft putty, and Fujifilm’s AI-powered endoscopic imaging technology. Read More
Medicare coverage of anti-obesity medications (AOM) — now CMS approved for cardiac patients — could drive up the federal deficit over the next decade, according to a new report issued by the Congressional Budget Office (CBO). Read More
The EU’s Environment, Public Health and Food Safety Committee (ENVI) has supported a legislative proposal that would grant up to 7.5 years of regulatory data privacy to pharmaceutical companies developing new drugs, effectively trimming six months of protection from the current eight years for some products. Read More
Three plastic syringe makers have received FDA warning letters describing violations related to the sale and distribution of plastic syringes made in China that have not been cleared or approved for sale or distribution in the U.S. Read More
An FDA proposed rule will establish criteria the agency will use to create two lists — drug products and categories of drug products — that present demonstrable difficulties for compounding (DDC Lists) and identify three categories of drug products on both DDC Lists. Read More
Devicemakers considering how to comply with the recently released Quality Management System Regulation (QMSR) will need to keep on hand a copy of the international standard ISO 13485 — the copyright-protected document that’s included only by reference in the new regulation. Read More
AstraZeneca has strengthened its oncology and rare disease portfolios with two buy-outs totaling close to $3.5 billion, the company has reported. Read More
Recommendations for drug sponsors to assess the impact of impaired renal function on pharmacokinetics (PK) and/or pharmacodynamics (PD) of an investigational drug, how to determine the recommended dosage, and how to provide appropriate labeling are the subjects of a recently released FDA final guidance. Read More