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

Perrigo disputes product-specific dosing devices

This article was originally published in The Tan Sheet

Executive Summary

FDA's recommendation that industry package liquid OTCs with uniquely appropriate dosing devices "may in fact lead to an increase in dosing errors" as consumers mix devices from different products, private labeler Perrigo says. The firm's associate director of regulatory affairs, Devon Morgan, writes in a Feb. 3 1letter that FDA should study consumer usage and understanding, and then provide "data-driven direction to industry." Perrigo also disagrees with other elements of FDA's November 2009 draft guidance on dosing devices for liquid OTCs, including the recommendation that "delivery devices should not be significantly larger" than a liquid drug's largest labeled dose; the firm cites a device's need to facilitate technical functionality and consumer handling. Allegan, Mich.-based Perrigo distributes 63 liquid OTC products and says it is implementing the voluntary industry dosage device provisions adopted by the Consumer Healthcare Products Association (2"The Tan Sheet" Feb. 8, 2010, In Brief)

You may also be interested in...



CHPA chimes in on OTC dosing device guidance

FDA's guidance on dosage delivery devices for liquid OTCs should adopt some measures from the Consumer Healthcare Products Association's voluntary industry guidelines on the subject, the trade group says. Among the recommendations in a Feb. 2 1letter, FDA should make milliliter the preferred primary unit of liquid measure, as CHPA says its member companies did. This echoes a change suggested by the Institute for Safe Medication Practices in a recent comment to the agency (2"The Tan Sheet" Feb. 1, 2010). CHPA also encourages FDA to limit spoon measures to either "teaspoonful" or "tablespoonful" to reduce confusion, and to tell firms to limit text on a dosing device that "risks obscuring important liquid measure markings." CHPA added dosing device language to its voluntary guidelines in November 2009 (3"The Tan Sheet" Dec. 7, 2009)

Singapore And Malaysia Test Joint Evaluation

A new work sharing pilot has been launched to evaluate jointly generic drugs intended for launch in Singapore and Malaysia.

Novartis And The Medicines Company: Five Things To Worry About

The $9.7bn acquisition hinges on the small interfering RNA inclisiran, but an ongoing cardiovascular outcomes trial, manufacturing hurdles, and reimbursement challenges provide subjects for concern.

Topics

UsernamePublicRestriction

Register

PS103803

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