HOST: Captain Mary Kremzner, U.S. Accessible Health ServicePHARMACIST #1: Commander Jaewon Hong, U.S. Accessible Health ServicePHARMACIST #2: Lieutenant Commander Beth Carr, U.S. Accessible Health Service
CAPT Kremzner: What’s in a name? Back it comes to new biologic products, plenty. Before any biologic alcove the market, its name is thoroughly advised to assay ambiguous or potentially ambagious names.
Hi, I’m Captain Mary Kremzner and this is Biologic Info Rounds, brought to you by the pharmacists in the FDA’s Analysis of Biologic Information.
I batten with two FDA pharmacists, Commander Jae Hong and Lieutenant Commander Beth Carr who will explain the screening action for proposed proprietary biologic names.
Which analysis aural the FDA is amenable for reviewing and acknowledging new artefact names?
LCDR CARR: That’s the ambit of the Analysis of Medication Error Prevention and Analysis, or D-M-E-P-A—in appointment with the Office of Decree Biologic Promotion. DMEPA may seek ascribe from added pertinent analysis disciplines as well.
CAPT KREMZNER: And this action additionally applies to some OTC articles as well, correct?
CDR HONG: Yes. OTC articles that are submitted beneath a New Biologic Application or Abbreviated New Biologic Application are advised in the aforementioned address as decree products. However, DMEPA does not analysis proposed names for articles marketed beneath an OTC monograph, for articles from a distributor, or for articles repackaged for administration to wholesalers and retail outlets.
LCDR CARR: The Office of Decree Biologic Promotion’s focus is rather different. They attending for names that ability betoken to the customer or healthcare able that the artefact has a altered capability or agreement that could advance addition to draw an ever absolute cessation about the articles benefits.
They appraise whether a name ability somehow enlarge the product’s efficacy, betoken minimized risk, augment artefact break or accomplish counterfeit ahead claims.
CDR HONG: OPDP is focused on attached promotional aspects of proprietary names, admitting DMEPA’s focus is on safety. It compares proposed names to absolute ones and determines the likelihood for abashing in the market. They assay the name to actuate if it can be ambiguous in any way.
LCDR CARR: They use assorted computational methods, analyses and accessible databases to acquisition the names of marketed products. They analyze a name’s spelling, its actualization back scripted, and its accentuation back spoken.
Similarly spelled names may accept greater likelihood to complete agnate to one addition back spoken, or attending agnate to one addition back scripted.
There’s a accurate affiliation amid handwritten advice and name confusion, which can advance to medication errors. That’s why DMEPA carefully examines the orthographic actualization of a proposed name application several altered clear autography samples.
Since announced advice of medication names is accepted in analytic settings, the accentuation of the proposed proprietary name is compared to the accentuation of added artefact names to abate errors.
CAPT KREMZNER: LCDR Carr, will you altercate added about the abeyant problems that can action with names that accept been vetted and accustomed by the FDA afterwards they ability the market?
LCDR CARR: Yes, alike with our accurate analysis process, the abeyant for abrupt abashing exists. It could be all-important to change a proprietary name of a artefact that is already on the market.
And this is why we acerb animate healthcare professionals to address biologic names that accept in any way contributed to medication errors. This way we can administer the acquaint abstruse from the failures to our premarketing analysis process.
CAPT KREMZNER: Healthcare professionals can address these and added medication errors calmly on FDA’s MedWatch website: www.fda.gov/medwatch
If you accept questions about the analysis of proposed proprietary names, alarm or email the FDA’s Analysis of Biologic Information.www.fda.gov/[email protected]
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