Description
On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85, 121 Stat. 823 (FDAAA), which includes the reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA IV).
Scope & Applicability
Product Classes
2Products subject to proprietary name evaluation under IND, NDA, or ANDA; Drug products subject to IND, NDA, or ANDA
Products with approved NDAs or ANDAs subject to SLC provisions.
Stakeholders
10Participants in the pilot program evaluating proprietary names
layman using the drug safely
The team should be multidisciplinary to ensure that different perspectives and viewpoints are brought to the process
Entity submitting development data and knowledge; Entity performing the work process for change
communication from physician to ward clerk to pharmacist to nurse
communication from physician to ward clerk to pharmacist to nurse; A health professional participant in simulation studies or user of references.
Allowed value for reporter qualification
Allowed value for reporter qualification
Participants in name simulation studies including physicians and pharmacists.
Relies on product name as critical identifier
Regulatory Context
Attributes
8Commercial name granted by an authority for marketing
whether a proprietary name implies an inconsistent dosing frequency
unrelated to the orthographic and phonological similarity
Visual similarity between names that may cause errors
Accounting for the potential for phonological error due to predictable phonological variance.; A characteristic used to evaluate name similarity.
The centers examine the orthographic appearance of the proposed name.; A characteristic used to evaluate name similarity.
Clinical development stage required for IND phase pilot submissions.
Characteristic discouraged in proprietary names
Identified Hazards
Hazards
2Safety concern addressed by PDUFA IV goals
Risk of inappropriate administration of extra doses
Related CFR Sections (11)
- 21CFR601.51§ 601.51 Confidentiality of data and information in applications for biologics licenses.
(a) For purposes of this section the biological product file includes all data and information submitted with or incorporated by reference in any application for a biologics license, IND's incorporated into any such application, master files, and other related submissions. The availability for publiRead full regulation →
- 21CFR601.50§ 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product.
(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged.Read full regulation →
- 21CFR314.430§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.
(a) The Food and Drug Administration will determine the public availability of any part of an application or abbreviated application under this section and part 20 of this chapter . For purposes of this section, the application or abbreviated application includes all data and information submitted wRead full regulation →
- 21CFR312.130§ 312.130 Availability for public disclosure of data and information in an IND.
(a) The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged.Read full regulation →
- 21CFR201.62§ 201.62 Declaration of net quantity of contents.
(a) The label of an over-the-counter drug in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination or numerical count and weight, measure, or size. The statement of quantity of drugs in tabletRead full regulation →
- 21CFR201.61§ 201.61 Statement of identity.
(a) The principal display panel of an over-the-counter drug in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →
- 21CFR201.60§ 201.60 Principal display panel.
The term principal display panel, as it applies to over-the-counter drugs in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall beRead full regulation →
- 21CFR314.125§ 314.125 Refusal to approve an NDA.
(a) The Food and Drug Administration will refuse to approve the NDA and for a new drug give the applicant written notice of an opportunity for a hearing under § 314.200 on the question of whether there are grounds for denying approval of the NDA under section 505(d) of the Federal Food, Drug, and CoRead full regulation →
- 21CFR201.10§ 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and suchRead full regulation →
- 21CFR202.1§ 202.1 Prescription-drug advertisements.
Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →
- 21CFR201.6§ 201.6 Drugs; misleading statements.
(a) Among representations in the labeling of a drug which render such drug misbranded is a false or misleading representation with respect to another drug or a device or a food or cosmetic.Read full regulation →
Related Warning Letters (1)
- 2021-04-06
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Neoingenium Labs, SA de CV
See Also (8)
- Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry (Status: Final)
- Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (Status: Final)
- Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act (Status: Draft)
- Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry (Status: Final)
- Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (Status: Final)
- Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (Status: Final)
- Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 (Status: Final)
- Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry (Status: Draft)