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This guidance describes for industry the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission2 (see sections II. Background and III. PDUFA IV Goal Dates).
Accurate identification of medications is critical to preventing medication errors and potential harm to the public. This guidance is intended to assist industry in the submission of a complete package of information that FDA will use in the assessment of:
1. the safety aspects of a proposed proprietary name, to reduce medication errors, and
2. the promotional implications of a proposed proprietary name, to ensure compliance with other requirements for labeling and promotion using our traditional review methods.
This guidance applies to proprietary name submissions for the following types of products:
• prescription drug products, including biologics, that are the subject of an investigational new drug application (IND), a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA)
• nonprescription drug products that are the subject of an IND, NDA, or ANDA
This guidance does not describe the methods used for evaluation of proposed proprietary names using the traditional review process, nor does the guidance describe the information needed by FDA to evaluate proposed proprietary names under the voluntary 2-year pilot program being conducted by CDER and CBER. That information can be found in the FDA concept paper entitled “PDUFA Pilot Project Proprietary Name Review,” dated September 2008.

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)). Examples of products that are addressed in this guidance include new molecular entities and new dosage forms of drug substances already controlled under the Controlled Substances Act (21 U.S.C. 812(c)). Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.2

Specifically, the guidance discusses the following:

• The definition of abuse potential

• Information on submitting an abuse potential assessment, including a proposal for scheduling

• A description of what constitutes an adequate abuse potential assessment

• Information for sponsors performing an assessment, including (1) the design and conduct of appropriate studies and investigations and (2) general administrative recommendations for submitting a proposal for scheduling

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

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Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”