Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Accutane Legislation Planned; Rep. Stupak Wants Mandatory Registries

This article was originally published in The Pink Sheet Daily

Executive Summary

The registry would require participation of all patients, prescribers, and dispensers of isotretinoin. Stupak calls into question the ability of Roche and FDA to manage such a registry.

You may also be interested in...



Allergan Tazoral PACT Program Will Register, Certify Physicians/Pharmacies

Mandatory pregnancy prevention registry will issue ID numbers upon physician/pharmacist certification and patient qualification. Tazarotene efficacy shown in moderate to severe psoriasis, but not in very severe disease, FDA says. Agency expresses concern about off-label use in acne.

Allergan Tazoral PACT Program Will Register, Certify Physicians/Pharmacies

Mandatory pregnancy prevention registry will issue ID numbers upon physician/pharmacist certification and patient qualification. Tazarotene efficacy shown in moderate to severe psoriasis, but not in very severe disease, FDA says. Agency expresses concern about off-label use in acne.

Accutane Prescriptions Would Be Limited To Approved Indication Under House Bill

Legislation from Reps. Stupak and Smith calls for mandatory registry for all Accutane users, prescribers and dispensers. The bill is based upon Roche's latest proposed risk management plan but adds some consumer protection provisions, such as an informed consent requirement for all patients.

Topics

UsernamePublicRestriction

Register

LL1134043

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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