FDA Reports Newly Added Guidelines for Drug and Device Makers
Shots:
- Opioid Abuse - Giving special priority to medication-assisted treatment(MAT) for patients to develop novel medicines for treatment of opioid use disorder encouraging drug sponsors to adapt new processes for evaluating effect and clinical benefit of MAT
- Depression- Plans to examine the onset of action of MDD for long-term or short- term usage; including those patients in TRD studies who did not respond to any prior treatments in TRD
- Smoking- To support nicotine replacement therapy(NRT) products as drugs- FDA issues two guidelines: To provide sponsors recommending on nonclinical information to support development and approval of orally inhaled nicotine-containing drug products; with an expected release of second guideline in fall
- Oncology- Plans for PBO usage whether it should or not be used in double-blind and randomized trials
- Osteoarthritis- Advises drug and device makers to set structural endpoints in trials and levels of disease progression- as current treatments address measures for pain and function
- FDA will now overtake the approval for gene therapies which was earlier under review with NIH- as per FDA's 700 proposals are pending presently
/ article | Ref: US FDA | Image: MDpharma
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