The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) compliance in reaction to Trial Master Files (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.”
The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder.
US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. The new guidance applies to clinical trial sponsors and investigators as well as Institutional Review Boards (IRB) and clinical research organizations (CRO) that must comply with 21 CFR Part 11 regulations pertaining to electronic records and signatures.
The US Food and Drug Administration (FDA) on Monday issued a final guidance detailing the circumstances in which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants.
The FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be classified as a drug or as a device.
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has prioritized guidances for topics including Unique Device Identification, 510(k) premarket notification issues and voluntary consensus standards for its 2018 fiscal year.
EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices .
As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released new guidance on human factors and usability engineering for medical device manufacturers.
The FDA released draft guidance on a new program aimed at expediting access to breakthrough medical devices.
The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers.