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CCH NetNews™
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(August 19, 2008)
Food and Drug Law
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New and Improved
Continuing to to provide you with the most
up-to-date, accurate information, CCH introduces new
enhancements for the Food,
Drug & Cosmetic Reporter and the Medical
Devices Reporter. These include:
- New food safety & security explanations,
incorporating Bioterrorism Act provisions
- Significant additions to the Hatch-Waxman
explanations on generic drug approvals
- New coverage of combination drug, biologics, and
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
The Food,
Drug & Cosmetic Reporter provides everything
you need to know about Food and Drug Regulations.
Full-text source covering federal and state laws and
regulations and court decisions that govern the
safety, effectiveness, purity, packaging and labeling
of food, drugs and cosmetics.
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Devices Reporter provides access to the full text
plus expert analysis of all laws and regulations
governing the classification, approval, manufacture,
and marketing of all medical diagnostic, and
radiological devices.
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Featured This Week:
Public meeting: nanotechnology report recommendations
— A public meeting on the Nanotechnology Task Force report recommendations
on foods (including dietary supplements), food and color additives (including
food contact substances), animal drugs and feeds, cosmetics, human drugs and
biologics, and medical devices was announced by the FDA. The report summarized
the state of the science for biological interactions with nanoscale materials
and recommended that the FDA coordinate with other federal agencies and the
private sector. The agency requested available data and information on the
effects of nanoscale materials on quality, safety, and, where relevant, effectiveness
of products subject to FDA oversight.
FDA
Notice,
¶43,710D.
Public hearing planned on advisory labeling of allergens
— At a September 16, 2008, public hearing in College Park, Maryland, the
FDA will discuss its long-term strategy to assist manufacturers in using allergen
advisory labeling to adequately inform allergic consumers and their caregivers.
Despite the labeling required by the Food Allergen Labeling and Consumer Protection
Act of 2004, §1998, allergenic substances may still be incorporated into
food products. Thus, the FDA seeks input on: how manufacturers currently use
advisory labeling, how consumers interpret different advisory labeling statements,
what wording is likely to be most effective in communicating to consumers
the likelihood that an allergen may be present in a food, and whether consumers
find advisory labeling helpful when making food purchasing decisions. The
FDA will present research on unintentional cross-contact of foods, consumer
studies, and other countries' use of advisory labeling.
FDA Notice,
¶43,711D.
Residual solvents in drugs: draft guidance released
— A draft guidance entitled “Control of Residual Solvents in Drug
Products Marketed in the United States” reflecting the FDA's recommendations
on how to comply with United States Pharmacopeia (USP) changes was published.
On July 1, 2008, the USP published a new test requirement for the control
of residual solvents, General Chapter <467> “Residual Solvents,” which
replaced USP General Chapter <467> “Organic Volatile Impurities.” The
change affects all compendia drug products marketed in the United States.
FDA Draft Guidance,
¶300,018.
Annual guidance agenda published
— An annual list of all FDA guidance documents was published by the agency.
Part of the FDA's “Good Guidance Practices” initiative, the list
is intended to inform the public of the existence and availability of all
current guidance documents. The names, addresses, and telephone numbers of
FDA contact persons are provided for each listed guidance.
FDA Notice,
¶43,709D.
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