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

CHPA Looks For FDA Reform Legislation To Deliver Monograph Changes In 2016

This article was originally published in The Tan Sheet

Executive Summary

CHPA chief Scott Melville is optimistic for OTC monograph reform progress in 2016. In an interview about CHPA's 2016 priorities, Melville also said state and local environmental regulations that touch OTC drugs will garner attention.

You may also be interested in...



PDUFA Negotiations Begin With FDA Seeking Review System Reform

During the inaugural negotiating session for renewal of PDUFA, which covers OTC switch and other nonprescription product NDAs, FDA says among its goals are “enhancements to the review processes.” The five-hour session included the ground rules for the talks and FDA and industry representatives also laid out their general wants and needs.

Unfettered OTC Purchasing With Pre-Tax Savings Tops CHPA Goals In 2015

CHPA is optimistic 2015 is the year “common sense” will restore OTC eligibility for health spending accounts. Speaking on the group’s priorities, President and CEO Scott Melville said CHPA will work to improve the OTC monograph system and to curb cough medicine abuse.

MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In

The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS108117

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