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The EMA Draft Guideline On A GCP Compliant Trial Master File

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.”


FDA publishes finalized guidance for buprenorphine depots

The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder.


New FDA guidance explains electronic record requirements for medical device clinical trials

US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations.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.


FDA Issues Guidance on Informed Consent Waivers for Minimal Risk Studies

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.


FDA Finalizes Guidance on Drug/Device Combination Product Classifications

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.


FDA Medical Device Guidance Documents to be Issued in 2018

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.


UK’s MHRA Unveils Human Factors Guidance for 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.


FDA Issues Guidance for New Breakthrough Devices Program

The FDA released draft guidance on a new program aimed at expediting access to breakthrough medical devices.


Here’s how FDA officials think you can legally promote off-label device, drug uses

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.