Australia’s Therapeutic Goods Administration released findings from a public consultation on proposed regulatory changes for personalized and 3D printed medical devices and said, based on the stakeholder feedback, it decided…
Health Canada is making further reductions in audit times for its Medical Device Single Audit Program for smaller companies with lower-risk products. Source: The GMP Letter
The FDA rejected a push to impose additional regulations on third-party servicers of medical devices, saying there is insufficient evidence to justify imposing new regulatory requirements. Source: The GMP Letter
FDA Commissioner Scott Gottlieb offered more perspective on new initiatives the agency is undertaking to improve medical device safety in remarks at the FDLI annual conference in Washington, D.C. Source:…
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Source: Drug Industry Daily
The FDA blasted Kolmar Korea for failures to investigate out-of-specification test results and to follow standard operating procedures after a September inspection of its Sejong City facility. Source: Drug Industry…
Generic drug price competition may come at the cost of relaxed manufacturing standards, according to a study published in the Journal of Operations Management. Source: Drug Industry Daily
Innovative antiretroviral HIV drugs may qualify for PDUFA fee waivers or refunds if the fee would be a significant barrier to development, according to new FDA draft guidance aimed at…
The FDA estimates that its generic drug approval pathway — which led to a record-setting year of generic drug approvals in 2017 — helped consumers save $11.8 billion in drug…
The Trump administration has formally delayed implementing an Obama-era rule that would have set a ceiling on drug prices for 340B hospital discount programs and fine those drug makers who…