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In the latest paper, Swissmedic and swissethics have added two new sections to the list of DCT elements, created three appendices, and made changes to the existing text. The two new sections cover trial oversight and responsibilities and organizational aspects for good clinical practice inspections.

HTAR states the JCA report 'should be factual and should not contain any value judgment.” Assessments of the certainty of study results must remain descriptive at the European level and avoid conclusions that may interfere with independent decision-making at the national level.

Industry groups, clinical researchers and patient advocates praised draft guidance from the US Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) that makes recommendations on the key information that should be included in informed consent documents used in human subjects research.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Industry and patient groups are asking the US Food and Drug Administration (FDA) to take a flexible approach when reviewing changes that come with switching third-party vendors that provide services for Risk Evaluation and Mitigation Strategies (REMS), also known as REMS administrators. The groups argue that a restrictive approach could limit patient access to life-saving drugs.

Two proposed regulations to limit the use of ethylene oxide (EtO) and the facilities that use the sterilizing agent could have a 'devastating” impact on the medtech industry and patient access to life-saving products, according to two industry groups.

The US Food and Drug Administration (FDA) is looking for up to nine drugmakers to join a pilot program intended to improve transparency for oncology drugs that rely on in vitro diagnostics to identify patients who may benefit from a particular treatment. Use of so-called companion diagnostics has increased with the proliferation of targeted therapies in recent years, especially in the oncology space.

In the US Food and Drug Administration (FDA) Accelerated Approval program, the tradeoff for early approval of medicines is that confirmatory evidence is required in the postmarket setting. In a special communication in JAMA Health Forum, health policy experts argue that FDA should put in place similar postmarket safeguards for any drug approval that has some uncertainty about clinical benefit.

The US Food and Drug Administration (FDA) has finalized guidance that lists non-clinical testing information the agency wants from sponsors of tissue containment systems used with gynecological and other types of laparoscopic power morcellators (LPMs). The guidance is meant to ensure containment systems are reasonably designed to catch cancerous tissue to prevent its spread.