FDA News


FDA Releases Draft Guidance on Benefit-Risk Determinations for Devices

On Thursday, September 6th, the FDA released a new draft guidance regarding benefit-risk determinations in medical device premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications. Uncertainty in Premarket Decisions Medical devices are required to demonstrate a “reasonable” assurance of safety and effectiveness; an “absolute” assurance of safety and effectiveness is […] READ MORE...


Opioid Epidemic: FDA Releases Draft Guidance on Endpoints for Medication-Assisted Treatment

On Monday, August 6th, FDA released a new draft guidance on clinical endpoints for demonstrating effectiveness of drugs for medication-assisted treatment for opioid use disorder (OUD), entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” Clinical Endpoints Currently, most clinical trials that evaluate the effectiveness of OUD treatments are using “reduction […] READ MORE...


FDA Releases Draft Guidance on Nonclinical Testing of Nicotine Products

On Friday, August 3rd, the FDA released a new draft guidance regarding nonclinical testing of orally inhaled nicotine-containing drug products. The draft guidance focuses on providing the nonclinical information needed to develop products for smoking cessation. Recommendations for Nonclinical Development According to the recently issued document, nonclinical toxicity assessments should include: General toxicity studies Developmental […] READ MORE...


FDA Medical Device User Fee Rates: Fiscal Year 2019

    On Monday, July 30th, FDA released the medical device user fee rates for fiscal year 2019. The total FY 2019 revenue amount, prior to adjustments, is $190,654,875. Medical device user fee rates are updated each fiscal year and must be paid at or before the time of submittal to avoid delays in the […] READ MORE...


FDA Outsourcing Facility User Fee Rates: Fiscal Year 2019

According to a recently released notice from the FDA, “the FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility.” Fees increased slightly between FY 2018 and FY 2019. These updated fee rates will be effective October 1, 2018 […] READ MORE...


FDA Prescription Drug User Fee Rates: Fiscal Year 2019

On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019. Prescription Drug Application Fees According to the Food, Drug, & Cosmetic (FD&C) Act, application fees should provide 20% of the total revenue, while program fees should provide the other 80%. Application fees are set at $202,064,400 […] READ MORE...


FDA Biosimilar User Fee Rates: Fiscal Year 2019

On Tuesday, July 31st, FDA released a notice with updated biosimilar user fee rates for fiscal year 2019. The base revenue for FY 2019 is $40,214,000, not adjusted for inflation or operating reserves. FDA has decided that the FY 2019 biosimilar application fee will be $1,746,745, which is the same as 2018.  Application fees are […] READ MORE...


FDA Generic Drug User Fee Rates: Fiscal Year 2019

On Friday, July 27th, FDA released a notice with updated generic drug user fee rates for fiscal year 2019. Under GDUFA II, user fees should total $493,600,000 each year, adjusted for inflation. The updated fees are effective October 1, 2018 through September 30, 2019. Generic Drug Fee Rates Fee Category FY 2019 Fee Rates ANDA […] READ MORE...


FDA Releases Draft Guidance on Nonprescription Drugs

On Tuesday, July 17th, FDA released a new draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.” The guidance discusses two different approaches for making nonprescription drugs more accessible to consumers. Regulatory Pathways for Nonprescription Drugs There are currently two different pathways for nonprescription drugs: Over-the-Counter Drug Review (OTC Monograph Process) New Drug Application (NDA) […] READ MORE...


FDA Approves 1st Drug to Treat Smallpox

On Friday, July 13th, FDA approved TPOXX (tecovirimat) for the treatment of smallpox. According to the World Health Organization (WHO), smallpox was eradicated in 1980; however, since eradication almost forty years ago, there have been concerns that the variola virus could be used as a bioweapon. What is smallpox? Smallpox is a highly contagious infectious […] READ MORE...