Regulatory Sciences
CBER Provides Sponsors with Policies & Procedures Regarding INTERACT Meetings
On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...
Clinical Research Solutions
FDA Issues Final Guidance Regarding Content & Format Requirements for ANDA Submissions
On Tuesday, September 25th, the FDA issued a guidance document entitled “ANDA Submissions – Content and Format.” The document, initially issued as a draft guidance in June 2014, provides sponsors...
Clinical Research Solutions
FDA Grants Two Mobile Medical Applications to be Used with the Apple Watch
On Tuesday, September 11th, FDA granted two de novo classification requests for mobile medical applications to be used with the Apple Watch. ECG App The first app, referred to as the ECG app,...
Clinical Research Solutions
FDA Considers Moving Medical Device Submissions to Electronic Format
On Thursday, September 13th, FDA published a proposed rule which would amend the current premarket submission requirements for medical devices. Background In July 2012, the Food and Drug...
Clinical Research Solutions
FDA Drafts List of Device Accessories to be Reclassified into Class I
On Thursday, August 16th, the FDA released a list of medical device accessories that have the potential to be reclassified as class I devices. Background According to section 513 of the Food, Drug, &...
Clinical Research Solutions
Opioid Epidemic: FDA Releases Draft Guidance on Endpoints for Medication-Assisted Treatment
On Monday, August 6th, FDA released a new draft guidance on clinical endpoints for demonstrating effectiveness of drugs for medication-assisted treatment for opioid use disorder (OUD), entitled...
Clinical Research Solutions
FDA Releases Draft Guidance on Nonclinical Testing of Nicotine Products
On Friday, August 3rd, the FDA released a new draft guidance regarding nonclinical testing of orally inhaled nicotine-containing drug products. The draft guidance focuses on providing the nonclinical...
Clinical Research Solutions
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...
Clinical Research Solutions
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)...
Clinical Research Solutions
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...