Notes in PHAR117 Jasti L03

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Published	10/02/2023	The Orange Book has contents for {{c1::Approved Drug Products with Therapeutic Equivalence}}
Published	10/02/2023	What information do you expect to find with drug labels?{{c1::Active IngredientDosage Form/RouteProprietary NameApplicant}}{{c2::StrengthApplication N…
Published	10/02/2023	How does a Prescription Drug move to OTC Status?{{c1::Section 503 (b)(3)}} of the Durham-Humphrey Amendment grants the FDA authority to switch prescri…
Published	10/02/2023	Generic Drugs: Questions and AnswersDo generic medicines work the same as brand-name medicines?{{c1::Yes}}Why brand name drugs look different from the…
Published	10/02/2023	A generic drug is {{c1::a copy of a brand-name drug}}, which must have the:{{c2::same quality same safety same strength}}
Published	10/02/2023	Myths about Generic DrugsGenerics…{{c1::are not as safe}}Generics…{{c2::are not as potent}}Generics…{{c3::take longer to act in the body }}
Published	10/02/2023	Abbreviated New Drug Application (ANDA)New dosage form compositionSame {{c1::route and dosage form}}Will have the same drug, {{c1::but …
Published	10/02/2023	Once the ANDA is submitted, it must undergo:{{c1::bioequivalence reviewplant inspectionchemistry/micro reviewlabeling review}}before the FDA reviews a…
Published	10/03/2023	What did/do the FDA and administrations do to make generic medicines more available?{{c1::Hatch-Waxman Act, or the Patent Term Restoration Act of 1984…
Published	10/03/2023	How frequently are generic drugs used?{{c1::1984}}: {{c2::14%}}{{c1::1999}}: {{c2::50%}}{{c1::2011}}: {{c2::80%}}{{c1::2021}}: {{c2::89%}}
Published	10/03/2023	OTC InformationNew OTC Drug{{c1::Sponsor/manufacturer submits an NDA as an OTC drug}}Prescription to OTC Switch{{c2::The drug company submits a supple…
Published	10/03/2023	OTC Drug ReviewAdvisory Panel Review{{c1::Panel reviews all known data or any submitted by company}}ANPR FR (Panel Report){{c2::Agency Input}}Category…
Published	10/03/2023	How Does the approval of fixed dose combination work? ‘Fixed-Dose Combinations (FDCs)’ 21 CFR 300.50“Two or more drugs {{c1::may be combined in a…
Published	10/03/2023	FDC - Important Characteristics{{c1::Contain two or more}} components of an established regimenRequire a {{c2::once- or twice-daily}} admini…
Published	10/03/2023	{{c1::Biological products}} are a diverse category of products and are {{c2::generally large, complex molecules. }}There are many types…
Published	10/03/2023	A {{c1::biosimilar}} is a biological product that is {{c2::highly similar to and has no clinically meaningful differences}} from a…
Published	10/03/2023	A {{c1::reference product}} is the {{c2::single biological product, already approved by FDA}}, against which a proposed biosimilar prod…
Published	10/03/2023	BiosimilarsAre biosimilars the same as generic drugs?NoBiosimilars and generic drugs are versions of brand name drugs and {{c1::may offer more afforda…
Published	10/03/2023	Where do these drug names come from?Use {{c1::INN - International Nonpropriety Name}}Has stems based on structure, MoA and type of agentUSAN {{c2…
Published	10/03/2023	Parallel Track and Accelerated Approval (1992){{c1::Parallel track}} provides wide access to pre-approved drugs for {{c2::AIDS patients failing AZT (a…
Published	10/03/2023	PDUFA: Prescription Drug User Fee Act (1992){{c1::User fee}} established by congressReview deadline mandated{{c2::Allowed for increased resources…
Published	10/03/2023	FDA Modernization Act FDAMA (1997)Substantial evidence can consist of {{c1::one adequate and well controlled study with “confirmatory evidence”}}&nbsp…
Published	10/03/2023	Why FDAMA?Slow and tedious review process within the agency due toLack of {{c1::funding for Staff}}Lack of {{c1::Training System}}Lack …
Published	10/03/2023	Orphan Drug Act ({{c1::1983}})Rare diseases {{c2::affecting fewer than 200,000 people}}Office of Orphan Product Development/FDADrugs, biologics, …
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