[HTML][HTML] FDA faces legal challenge over failure to disclose data on antibiotic resistance

PC Webster - 2013 - Can Med Assoc
That question lies at the core of a legal challenge launched in the United States District
Court of Columbia in December 2012 in which the Washington, DC–based Government …

[HTML][HTML] Who's writing the script?

A Miller - 2013 - Can Med Assoc
FDA faces legal challenge over failure to disclose data on antibiotic resistance: Do “trade
secrets” trump the public interest in containing antibiotic resistance associated with …

Exclusivity, Risk, CMS Payments, REMS Sought To Protect Antibiotic Use

B Moscovitch - Inside Washington's FDA Week, 2010 - JSTOR
Lawmakers To Address Antibiotic Pipeline... begins on page one payments and public-
private partnerships as possible ideas for future bills.“We clearly have a desperate need for …

Transparency at the US Food and Drug Administration

RM Califf - The Journal of Law, Medicine & Ethics, 2017 - journals.sagepub.com
Given the profound public health and economic ramifications of decisions made by the US
Food and Drug Administration, the degree to which FDA activities should reflect an …

Dangerous times: The FDA's role in information production, past and future

A Kapczynski - Minn. L. Rev., 2017 - HeinOnline
These are challenging times for the Food and Drug Administration. Congress passed a so-
called right-to-try law in May 2018, sharply limiting the Agency's oversight of the use of …

The big data regulator, rebooted: Why and how the FDA can and should disclose confidential data on prescription drugs and vaccines

CJ Morten, A Kapczynski - Cal. L. Rev., 2021 - HeinOnline
and How the FDA Can and Should Disclose Confidential Data on Page 1 The Big Data
Regulator, Rebooted: Why and How the FDA Can and Should Disclose Confidential Data on …

[CITATION][C] Government Accountability Project Sues FDA To Obtain Antibiotic Data

A Busch - InsideHealthPolicy. com's FDA Week, 2012 - JSTOR

[CITATION][C] Lawmakers Consider Antibiotic Resistance Hearing; Tax Breaks Pushed

B Moscovitch - Inside Washington's FDA Week, 2010 - JSTOR

[CITATION][C] Antibiotic Preservation Advocates Counter GOP's Science Dearth Contentions

B Moscovitch - Inside Washington's FDA Week, 2011 - JSTOR

[CITATION][C] E&C Democrats Request Hearing On Antibiotic Resistance

N Bompey - InsideHealthPolicy. com's FDA Week, 2013 - JSTOR