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drug/biologic safety and/or effectiveness through noninterventional studies, the FDA has published long-awaited draft guidance on designing and analyzing such studies with…

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…

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…

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…

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…

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…

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…

AstraZeneca has strengthened its oncology and rare disease portfolios with two buy-outs totaling close to $3.5 billion, the company has reported. Source: Drug Industry Daily

This edition of Quick Notes looks at inhaler price caps, a voluntary product recall, Warning Letter and fed support for right to repair. Source: Drug Industry Daily

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…