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New draft guidance issued by the U.S. Food and Drug Administration (FDA) advises manufacturers of Class III devices subject to premarket approval (PMA) requirements on when to use certain PMA supplements.
The Global Harmonization Task Force’s (GHTF) Study Group 1 has issued new guidance for regulatory authorities, conformity assessment bodies and the device industry on the documentation of evidence necessary to show conformity to regulatory requirements.
The European Medicines Agency (EMEA) has released for comment draft guidance on acceptable limits of metal residues in drug substances and excipients (inert substances that aid in binding a pill or tablet).
The FDA will update its cGMP quality systems (QS) guidance to conform with international pharmaceutical QS guidelines,
the agency said March 23 at a Drug Information Association
conference.
The FDA is proposing rules in a draft guidance that would bar any person with more than $50,000 in ties to drug and device companies from participating in an agency advisory committee.
The FDA is proposing rules in a draft guidance that would bar any person with more than $50,000 in ties to drug and device companies from participating in an agency advisory committee.
Sponsors cannot assume that a data monitoring committee (DMC) or data safety monitoring board is appropriate for every clinical trial, according to an expert.
An FDA draft guidance released last week provides recommendations on reporting data from studies of diagnostic tests and identifies common "inappropriate practices."