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CCH NetNews™
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(July 1, 2008)
Food and Drug Law
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New and Improved
Continuing to to provide you with the most
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enhancements for the Food,
Drug & Cosmetic Reporter and the Medical
Devices Reporter. These include:
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incorporating Bioterrorism Act provisions
- Significant additions to the Hatch-Waxman
explanations on generic drug approvals
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device products
- More detailed explanations on drug, vet drug,
and device user fees
- Updated, comprehensive coverage of
over-the-counter drug monographs
- Additional reporting on food and drug good
manufacturing practices
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Featured This Week:
FDA proposes that many OTC ingredients are not GRASE
— The FDA proposed that certain ingredients in over-the-counter (OTC)
drug products are not generally recognized as safe and effective (GRASE) or
are misbranded. The FDA issued the proposed rule because it did not receive
any data on these ingredients in response to a request on December 31, 2003
(68
Federal Register 75585). The FDA noted that the names
of several active ingredients changed from the way they appeared in the December
31, 2003
Federal Register notice. Based on submissions received
from the 2003 notice, certain products including: lubricants and vaginal moisturizers,
nasal moisturizers, urinary/analgesics/antiseptics, wrinkle removers, lanolin
for use as a nipple protectant, and ichthammol for use in drawing salves,
were not included in the proposed rule.
FDA Proposal,
¶46,128D.
HHS, China sign progress agreement on 2007 MOU
— On June 18, 2008, HHS Secretary Mike Leavitt signed a Joint Progress
Statement with the Honorable Li Changjiang, Minister of the General Administration
of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People’s
Republic of China. The statement outlines steps taken by both nations in implementing
their December 2007 Memorandum of Agreement (MOA) on food and feed safety.
The MOA established a bilateral mechanism to provide greater information and
other assurances to enhance the safety of food and feed products traded between
the two countries. Since its signing, the FDA and AQSIQ have planned a joint
implementation work strategy and have begun the initial steps called for in
the MOA.
HHS News Release.
Warning letters issued addressing fake cancer cures
— Warning Letters were sent by the FDA to 23 U.S. companies and two foreign
individuals marketing a wide range of products fraudulently claiming to prevent
and cure cancer. . The products contain ingredients such as bloodroot, shark
cartilage, coral calcium, cesium, ellagic acid, Cat's Claw, the herbal tea
Essiac, and mushroom varieties such as Agaricus Blazeii, Shitake, Maitake,
and Reishi. Because these products claim to cure, treat, mitigate or prevent
disease, and these products have not been shown to be safe and effective for
their labeled conditions of use, they are unapproved new drugs marketed in
violation of the FDC Act. The warning letters are part of the FDA's ongoing
efforts, in collaboration with the Federal Trade Commission (FTC) and Canadian
government agencies, to prevent deceptive products from reaching consumers.
FDA News Release,
¶100,916.
Boxed warnings required for conventional antipsychotics
— Recently the FDA exercised its new authority under the Food and Drug
Administration Amendments Act of 2007 to require manufacturers of “
conventional” antipsychotic drugs to make safety-related changes to
prescribing information on labeling, to add black box warnings about an increased
risk of death associated with the off-label use of these drugs to treat behavioral
problems in older people with dementia. In 2005, the FDA required black box
warnings, the strongest warnings possible, for “atypical” antipsychotic
drugs. The warning for both classes of drugs will say that clinical studies
indicate that antipsychotic drugs of both types are associated with an increased
risk of death when used in elderly patients treated for dementia-related psychosis.
FDA News Release,
¶100,915.
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