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Headlines
The FDA confirmed a 2011 interim final rule that permits the
agency to detain food if there is any reason to believe that it may
be adulterated or misbranded, for 20 calendar days, with a possible
10 calendar day extension, if needed, to initiate legal action. The
final rule, which is effective immediately, implements the requirements
of the FDA Food Safety Modernization Act (FSMA) (P.L. 111–353),
signed into law on January 4, 2011. The FDA received a number of comments
requesting clarification on the FSMA section 207 amendment to Food,
Drug and Cosmetic Act section 304(h)(10(A) (21 U.S.C. 334(h)(1)(A)),
in particular, the phrase ‘‘reason to believe that an
article of human or animal food is adulterated or misbranded.”
The agency declined to offer any specific definition, saying instead
that it will consider the individual facts in each particular situation
to inform its reason to believe that an article of food is adulterated
or misbranded. FDA Order, ¶40,473
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After nearly 12 years, the FDA is finalizing its 2001 Interim
rule to bring FDA regulations in compliance with provisions of the
Children’s Health Act of 2000. The amendments contained in
this Final rule are designed to provide additional safeguards for
children enrolled in clinical investigations of FDA-regulated products.
The requirements of this Final rule are effective March 28, 2013.
Four substantive changes have been made to the interim rule: (1) the
definition of guardian has been modified, (2) the definition of permission
has been modified, (3) subparagraph (a) has been added to 21 CFR sec.
50.51 to require that institutional review boards assess the level
of risk to children in clinical investigations, and (4) a phrase has
been added to 21 CFR sec. 50.55(e) to make it clear that the exception
for emergency research applies to research in children. FDA
Order, ¶40,474
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The FDA wants the public to comment by March 8, 2013, on the
proposed implementation of its prescription drug labeling initiative
and on a proposed pilot project on voluntary conversion of drug labeling
to the new format. The agency noted that only 15 percent of relevant
labeling has been converted to the new format, commonly referred to
as the ‘‘Physician Labeling Rule” (PLR) format,
but it stressed voluntary compliance and did not note that the remaining
labeling is required to be converted to the PLR format by June 30,
2013, according to a 2006 final rule. FDA Proposal, ¶46,195
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The FDA has released final guidance entitled, “Guidance
for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure
by Clinical Investigators”. The guidance, which is available
on the FDA website, addresses compliance with the requirements of
21 CFR Part 54. This document reflects the agency’s latest thinking
on the subject. It is not legally binding, but recommends best practices.
The guidance describes study sponsors’ obligations to obtain
all required financial information from each investigator before he
or she begins participation in the research. If an investigator who
is not employed by the sponsor stops participating before the project
is complete, the obligation extends for one year after the investigator
ends the work. The sponsors’ due diligence obligations also
are addressed. FDA Notice, ¶42,267
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The FDA has issued a draft guidance providing responses to questions
the agency has received regarding the issuance of civil money penalties
(CMPs) for violations of provisions of the FDC Act relating to the
sale of tobacco products in retail outlets. Titled “Civil Money
Penalties for Tobacco Retailers: Responses to Frequently Asked Questions,”
the draft guidance provides responses to questions relating to the
imposition of CMPs for violations of the requirement that tobacco
products may not be sold or distributed in violation of FDA’s “Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and Adolescents.” Comments on the
draft guidance must be submitted to the agency by April 9, 2013, if
they are to be considered in the final version of the guidance. FDA
Notice, ¶42,260
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The FDA’s Center for Drug Evaluation and Research has
issued a final guidance document that will help applicants for human
prescription drugs and biologics to comply with the new labeling content
and format requirements set forth in the Physician Labeling Rule (PLR)
(71 FR 3922), which published in the Federal Register on January 24,
2006. Titled “Labeling for Human Prescription Drug and Biological
Products—Implementing the PLR Content and Format Requirements,”
the guidance is specifically intended to assist applicants in the
creation of professional labeling consistent with the content and
format requirements of the FDA regulations contained in 21 CFR secs.
201.56 and 201.57. FDA Notice, ¶42,263
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Mississippi law would not support a case against the brand name
manufacturer of a medication by an individual who took and was harmed
by a generic version of the medication made by another manufacturer.
The motion of Medicis Pharmaceuticals Corp. was dismissed, but the
plaintiff, Patricia Washington, was allowed to file an amended complaint
pursing a different theory of liability. Washington’s theory
that Medicis was liable for failing to inform consumers of potential
side-effects of the medication because Medicis was the innovator of
the drug would most likely not be supported by the Mississippi Supreme
Court had they the opportunity to review this case and legal theory.
Washington, however, may have an opportunity to pursue her claims
under a common-law negligence theory and was given leave to amend
her complaint to argue liability under that legal theory. Washington
v Medicis Pharmaceuticals Corp., et al., S.D. Miss., ¶39,276
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