Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Sunscreen Industry Asks FDA For Flexibility Despite Guidances' Rigidity

Executive Summary

FDA latest sunscreen guidances incorporate little industry input and are met with frustration and hope among industry stakeholders. The PASS Coalition and the Natural Products Association weigh in on future cooperation between FDA and industry under SIA.

You may also be interested in...



FDA Budget Request Proposes OTC Monograph User Fees And ‘Field Alerts’

In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.

OTC Monograph User Fee Goals Document Beats Authorization To Finish Line

While still awaiting the addition of OTC user fees to pending user fee authorization, and congressional approval of the overall package, FDA has developed guidelines closely tracking Sens. Isakson and Casey's OTC proposal. FDA plans a webinar to update industry on how OTC user fees would work.

OTC Monograph User Fee Goals Document Beats Authorization To Finish Line

While still awaiting the addition of OTC user fees to pending user fee authorization, and congressional approval of the overall package, FDA has developed guidelines closely tracking Sens. Isakson and Casey's OTC proposal. FDA plans a webinar to update industry on how OTC user fees would work.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119578

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel