Freedom of Information Act | FOIA
The Freedom of Information Act provides that citizens can request documents from the government, so long as they are not in some way classified or otherwise restricted. The text of law for the Freedom of Information Act is found at 5 U.S.C. § 552, as amended.
FOIA allows anyone to request copies of records not normally prepared for public distribution. FOIA pertains to existing records only and does not require agencies to create new records to comply with a request. It also does not require agencies to collect information they do not have or to do research or analyze data for a requestor. In addition, FOIA requests must be specific enough to permit an FDA employee who is familiar with the subject matter to locate records in a reasonable period of time.
With requests made of the FDA with respect to drugs they have approved (or denied approving) the governing laws and rules are found at the procedures set forth in 21 CFR Part 20 and the procedures set forth at (http://www.fda.gov/opacom/backgrounders/foiahand.html),
Zelnorm Records Requested from FDA
New Guestbook
Like this lens? Want to share your feedback, or just give a thumbs up? Be the first to submit a blurb!
FOIA Requests
The following are links to news stories concerning FOIA requestssent to the FDA about recalled drugs.
Lawyers Seek FDA Zelnorm Documents through Freedom of Information Act
Lawyers Working on Zelnorm Lawsuits Have Filed A F more...0 points
How Did Ketek Ever Get Approved?
How Did Ketek Get Approved? What can you do if you more...0 points
FDA FOIA - Biomedical Tissue Services, Ltd.
Request for Documents from FDA0 points
Drug News RSS
Fetching RSS feed... please stand byKetek Lawsuits
Learn about the Senate investigation into the FDA mistakes in approving Ketek.
Fetching RSS feed... please stand byby mmonheit
This Lens is maintained by Michael Monheit, Esq. of the Philadelphia based lawfirm of Anapol Schwartz Weiss Cohan Feldman & Smalley.
(more)
