FDA Reports Newly Added Guidelines for Drug and Device Makers

 FDA Reports Newly Added Guidelines for Drug and Device Makers

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
  • OncologyPlans 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

Click here to read full press release/ article | Ref: US FDA | Image:  MDpharma

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post