Recently Posted Guidance Documents on Biosimilarity; User fees; Administrative / Procedural

Administrative / Procedural

6/7/2018 Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff

User fees

6/6/2018 Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief

Biosimilarity

6/4/2018 Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry