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Drugmaker sues FDA over generic ADHD drug reclassification

FDLI SmartBrief | May 18, 2015

Mallinckrodt Pharmaceuticals claims in a lawsuit that the FDA overstepped its authority when the agency declared that two companies' generic versions of Johnson & Johnson's Concerta were not bioequivalent and thus cannot automatically be substituted at the pharmacy counter. The Wall Street Journal (tiered subscription model) (05/14)


Activists seek to overturn patents for Gilead hepatitis C drug

FDLI SmartBrief | May 21, 2015

Pharmacy's bankruptcy plan covers payout to meningitis outbreak victims

FDLI SmartBrief | May 20, 2015

Warner Chilcott holds settlement talks with government authorities

FDLI SmartBrief | May 15, 2015

J&J to seek approval of over 10 new drugs by 2019

FDLI SmartBrief | May 21, 2015

FDA may expand drug residue testing in milk

FDLI SmartBrief | May 19, 2015

FDA: SGLT2 inhibitors may cause ketoacidosis in diabetes patients

FDLI SmartBrief | May 18, 2015

Guidance on using adaptive design in medical device studies issued by FDA

FDLI SmartBrief | May 19, 2015

Draft rule would increase reporting of animal antibiotics sales

FDLI SmartBrief | May 20, 2015

Endo to purchase generic-drug maker Par Pharma

FDLI SmartBrief | May 19, 2015


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FDLI SmartBrief | May 22, 2015

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FDLI SmartBrief | May 22, 2015

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FDLI SmartBrief | May 21, 2015

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FDLI SmartBrief | May 21, 2015

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FDLI SmartBrief | May 20, 2015




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