Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA

Author:

Bate Roger,Mathur Aparna,Lever Harry M.,Thakur Dinesh,Graedon Joe,Cooperman Tod,Mason Preston,Fox Erin R.

Publisher

Elsevier BV

Subject

Pharmacology,Toxicology

Reference9 articles.

1. Longer patents for increased generic competition: the Waxman Hatch Act after one decade;Grabowski;Pharmacoeconomics,1996

2. Brand Loyalty, Generic Entry, and Price Competition in Pharmaceuticals in the Quarter Century after the 1984 Hatch–Waxman Legislation NBER Working Paper No. 16431;Berndt,2010

3. Generic substitution issues: brand–generic substitution, generic–generic substitution, and generic substitution of narrow therapeutic index (NTI)/critical dose drugs;Paveliu;Maedica,2011

4. Drug shortages: a complex health care crisis;Fox;Mayo Clin. Proc.,2014

5. Generic and branded levothyroxine preparations are not bioequivalent in children with congenital hypothyroidism;Carswell;Clin. Thyroidol.,2012

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