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Effective November 18, 2013, the FDA will require that animal
food labels list the common or usual names of all color additives
that are required to be certified by the agency. The FDA published
the proposed rule in the November 23, 2009, Federal Register proposing
a regulation that would require that the common or usual name of all
color additives that are required to be certified by FDA be listed
on the label of animal foods. Additionally, the proposed rule suggested
how color additives not certified by the FDA should be declared on
the ingredient list of animal foods. The final rule will amend FDA’s
animal food regulations to include certain requirements of the 1990
Amendments, as was previously done with the human food regulations.
According to the agency, the two year effective date will allow animal
food manufacturers time to deplete their current label inventories
as they make the transition to the new label. The FDA did not expect
the final rule to require a major label redesign because it would
likely only necessitate minor changes in wording on the ingredient
list.
FDA Order, ¶40,440
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The manufacturer of a cigarette or smokeless tobacco product
with a trade or brand name that is also the trade or brand name of
a nontobacco product would be able to continue to use the name if
the tobacco product was sold in the United States on or before June
22, 2009 under a recent FDA Proposal. The proposed rule would amend
the FDC Act to ensure manufacturers would not have to monitor whether
a trade or brand name is registered for a nontobacco products after
the initiate sale of the tobacco product. This proposal would still
prevent tobacco product manufacturers from exploiting imagery and
consumer identification associated with the trade or brand name of
a nontobacco product by protecting nontobacco products that precede
the sale of tobacco products with the same name. These rules will
also prevent nontobacco companies from creating brand names used by
tobacco brands to the detriment of the tobacco manufacturers.
FDA Proposal, ¶46,178
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The FDA published a draft guidance titled “Guidance for
Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire
and Accompanying Materials for Use in Screening Frequent Donors of
Blood and Blood Components” that recognizes the abbreviated
donor history questionnaire and accompanying materials (aDHQ documents),
version 1.3 dated August 2011, as an acceptable mechanism for collecting
blood donor history information from frequent donors of blood and
blood components. The aDHQ documents will provide blood establishments
that collect blood and blood components with a specific process for
administering questions to frequent donors of blood and blood components
to determine their eligibility to donate. The guidance also provides
information to licensed manufacturers who choose to implement the
acceptable aDHQ documents on how to report the manufacturing change
consisting of the implementation of the aDHQ documents.
FDA Notice, ¶42,153
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The FDA published a draft guidance titled “Evaluating
the Effectiveness of Anticoccidial Drugs In Food-Producing Animals” discussing
general considerations for the evaluation of the efficacy of anticoccidial
drugs in poultry, minor species and food-producing mammals. The draft
guidance provides recommendations regarding protocol development,
study conduct, animal welfare, substantial evidence of effectiveness,
feed preparation, drug assays, and combination approvals. Additionally,
the draft document discusses considerations for studies used to substantiate
effectiveness of anticoccidial drugs in poultry, including battery
studies and commercial field studies. The draft document supersedes
a previous Center for Veterinary Medicine draft guidance titled “Draft
Guideline for the Evaluation of The Efficacy of Anticoccidial Drugs
and Anticoccidial Drug Combinations in Poultry.
FDA Notice, ¶42,157
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In a report titled “A Review of FDA's Approach to Medical
Product Shortages,” the agency noted that drug and other medical
product shortages have the potential to adversely affect patient care
by delaying treatment or forcing the use of second-choice products.
The FDA highlighted that recent shortages involved drugs for life-threatening
conditions and, in some cases, the product in shortage has been the
only product for the patient’s condition. The agency conducted
a review of medical product shortage activities in four medical product
Centers in the FDA and talked to external parties in the drug arena
to gain perspectives on the problem. The report identified a number
of respects in which the FDA’s internal processes might be improved,
so that the agency could maximize its contribution to the prevention
and mitigation of shortages.
The FDA identified five areas to be addressed immediately, including:
(1) letters to drug manufacturers reminding them of their current
legal obligations to notify the FDA in advance of the discontinuation
of certain drugs and urging voluntary notification of the FDA of other
potential disruptions to the supply of drugs that are not currently
required, as soon as they become aware of them; (2) development of
guidance and regulations that clarify and enhance the information
on potential drug shortages that is submitted by industry; (3) additional
staffing resources for the FDA’s efforts to prevent and mitigate
shortages; (4) support of legislation that requires early notification
by manufacturers for drug shortages and provides new authority to
the FDA to enforce these requirements; and (5) implement and maintain
a database that can analyze the characteristics of drug shortages.
FDA Report, ¶400,040
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