FDA Clarifies Its Approach to Postmarket Studies and Clinical Trials
In a draft revision of an April 2011 guidance, the FDA has laid out its current thinking on when the agency may require postmarket studies or clinical trials for approved…
Reckitt Settles Multistate Suboxone Claims for $700 Million
Reckitt Benckiser (RB Group) has agreed to pay $700 million to settle multiple lawsuits filed by states in federal courts over marketing practices for its addiction treatment drug Suboxone (buprenorphine).…
IMDRF Flags Lack of ‘Global Alignment’ in Cybersecurity
Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says, in a new draft guidance that calls for “convergence of global healthcare cybersecurity…
483 Roundup: FDA Hits Six Firms for Quality Management Lapses
The FDA cited six devicemakers for a variety of quality problems uncovered during the agency’s inspections of their facilities. Source: The GMP Letter
FDA Creates New Safer Technologies Program
The FDA is introducing a new review program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or…
FDA Pilots Accreditation Scheme for Conformity Assessment
The FDA is establishing a pilot accreditation scheme for conformity assessment (ASCA) whereby testing laboratories may be accredited by accreditation bodies to assess the conformance of a device within certain…
EC Releases Guidelines on Benefit-Risk Analysis for Phthalates
The European Commission released final guidelines for devicemakers, notified bodies and regulators on how to perform a benefit-risk analysis for phthalates in medical devices. Source: The GMP Letter
FDA’s Top Ten GMP Citations for FY 2019
An FDAnews analysis of the FDA’s Form 483 inspection reports for fiscal year 2019 shows devicemakers continue to be tripped up at the same old hurdles. Source: The GMP Letter
483 Roundup: Five Companies Cited for Various Problems
Five drugmakers were cited in FDA inspections for violations that ranged from inadequate smoke studies to a “cascade of failure” at one facility. Source: Drug GMP Report
FDA Warns Galt Pharmaceuticals for Misleading Email
The FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter to Galt Pharmaceuticals for sending an email to doctors about its insomnia pill Doral (quazepam) that left out…
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