Background
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is seeking feedback on its draft guideline for the evaluation of the efficacy and safety of non-steroidal anti-inflammatory drugs (NSAIDs).
This guideline has been developed to specify recommendations for the design, conduct, and evaluation of clinical studies for NSAIDs to be provided in support of an application to register a new NSAID, or to vary the indications of an already registered NSAID. It provides recommendations on how to appropriately demonstrate clinical efficacy through clinical trials where the selection of control and efficacy endpoints is regarded as a key issue for obtaining conclusive information. The guideline also includes safety aspects when studies are undertaken to assess efficacy.
We invite submissions from 1 November 2024 to 20 January 2025 on the draft guideline for the evaluation of the efficacy and safety of non-steroidal anti-inflammatory drugs.
Please note: Submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential (see public submission coversheet).
Making a submission
Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published. Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.
Please send your written submission and coversheet by email or post to:
Email: enquiries@apvma.gov.au
Post:
Efficacy and Safety Team – Risk Assessment Capability
Australian Pesticides and Veterinary Medicines Authority
PO Box 574
Canberra ACT 2601