FDA devotes new resources to upgrading generic drug safety: But in some instances, the industry is pushing back

P and T

Volumn 39, Issue 5, 2014, Pages

  Barlas, Stephen ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; ETOMIDATE; FLUOXETINE; GENERIC DRUG; GLATIRAMER; PAROXETINE; SERTRALINE;

ARTICLE; COMPUTER MODEL; DRUG APPROVAL; DRUG COST; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; HUMAN; PATENT; POLICY;

EID: 84901443900     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (15)

1. FDA. Regulatory action against Ranbaxy. Available at: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforce-mentactivitiesbyfda/ucm118411.htm. Accessed March 28, 2014.
2. FDA. Wockhardt Limited 7/18/13: warning letter. Available at: http://www.fda.gov/iceci/enforcementactions/warninglet-ters/2013/ucm361928.htm. Accessed March 28, 2014.
3. Generic Pharmaceutical Association. Comments of the Generic Pharmaceutical Association for Docket No. FDA-2012-D-0880-0006, Draft Guidance for Industry Generic Drug User Fee Amendments of 2012: questions and answers. Available at: http://www.gphaonline.org/media/wysiwyg/cms/GPhA_GDUFA_Q_A_Response_2.pdf. Accessed March 28, 2014.
4. FDA. Global initiative. Available at: http://www.fda.gov/AboutFDA/GlobalInitiative/default.htm?utm_source=fda&utm_medium=website&utm_term=GlobalizationReport&utm_content=f1&utm_campaign=HomePageSpotlight. Accessed March 28, 2014.
5. Mylan. Mylan completes acquisition of Agila to create leading global injectables platform. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=811637. Accessed March 28, 2014.
6. FDA. Agila Specialties Private Limited initiates voluntary nation-wide recall of 10 lots of etomidate injection 2 mg/mL-10 mL and 20 mL due to the presence of particulate matter and/or illegible and missing lot number and/or expiry date. Available at: http://www.fda.gov/Safety/Recalls/ucm386547.htm. Accessed March 28, 2014.
7. FDA. Update: Bupropion hydrochloride extended-release 300 mg bioequivalence studies. Available at: http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm322161.htm. Accessed March 28, 2014.
8. FDA. Statement of intent between the Food and Drug Administration of the United States of America and the Ministry of Health and Family Welfare of the Republic of India on co-operation in the field of medical products. Available at: http://www.fda.gov/downloads/InternationalPrograms/Agreements/MemorandaofUnderstanding/UCM385494.pdf. Accessed March 28, 2014.
9. FDA. Generic Drug User Fee Amendments of 2012. Available at: http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf. Accessed March 28, 2014.
10. FDA. Guidance for industry: ANDA submissions-refuse-toreceive standards. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM370352.pdf. Accessed March 28, 2014.
11. Supplemental applications proposing labeling changes for approved drugs and biological products. Federal Register 2013:78(219):67985-67999. Accessed March 28, 2014.
12. Generic Pharmaceutical Association. Comments on generic labeling rule by GPhA and other groups. Available at: http://www.gphaonline.org/media/cms/Supply_Chain_Sign_On_Letter_to_FDA_on_Labeling_FINAL.pdf. Accessed March 28, 2014.
13. Public Citizen. Comments on proposed rule: "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" Available at: http://www.citizen.org/documents/Comments%20on%20NPRM%203-12-14.pdf. Accessed March 28, 2014.
14. Towfic F, Fund JM, Fowler KD, et al. Comparing the biological impact of glatiramer acetate with the biological impact of a generic. PLOS ONE, January 8, 2014. doi:10.1371/journal.pone.008375. Available at: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0083757. Accessed March 28, 2014.
15. FDA. Sandoz Incorporated 11/18/11: warning letter. Available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm314931.htm. Accessed March 28, 2014.