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CCH NetNews™
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(August 12, 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:
FDA sets fiscal year 2009 prescription drug user fees
— Fiscal Year (FY) 2009 prescription drug user fee rates were announced
by the FDA. The FDC Act requires that rates be announced by August 1 so that
users have a 60-day notice of rate increases before the start of each new
fiscal year on October 1st. Base revenue amounts for application fees, establishment
fees, and product fees were established by the Prescription Drug User Fee
Amendments of 2007 (PDUFA IV, Title 1 of the Food and Drug Administration
Amendments Act of 2007). Payment instructions are provided in the notice.
FDA
Notice,
¶43,708D.
House passes bill to let FDA regulate tobacco
— On July 30, 2008, the U.S. House of Representatives, passed the Family
Smoking Prevention and Tobacco Control Act (H.R. 1108), which would grant
the FDA authority to regulate the advertising, marketing, and manufacturing
of tobacco products. The bill's sponsors believe it would keep manufacturers
from targeting advertisements to young people and assist current smokers in
quitting. The FDA would: set up a new center for tobacco regulation; issue
regulations restricting advertising, promotion, and access to products; prohibit
descriptors such as "light," "mild," and "low" on
labels and in advertising; and require stronger warnings on cigarette packaging.
The bill would permit the HHS Secretary to establish tobacco product standards
to protect the public health, but it would reserve to Congress the power to
ban any tobacco products or reduce nicotine levels to zero. The measure would
also prohibit cigarettes from containing any artificial or natural flavors
other than tobacco or menthol, such as herbs and spices, or strawberry, cinnamon,
clove, or coffee flavors.
CCH Washington News Bureau; House of Representatives,
White House News Releases.
Comments requested: foods with added drugs, biologics
— The FDA sought guidance on how to implement Section 912 of the Food
and Drug Administration Amendments Act of 2007, FDC Act § 301(II), which
prohibits foods with added drugs or biological products, with certain exceptions.
The FDA wants to know how the prohibition will affect infant formula, dietary
supplements, animal feeds, and food contact substances. The agency needs information
on clinical investigations of drugs/biologics added to foods because some
of these foods may be exempt from the prohibition while others will be subject
to it. As well, the agency seeks to define the phrase "marketed in food" because
food that contained drugs and biologics marketed in foods prior to their approvals
or the initiation of substantial clinical investigations will be exempt. The
FDA must define which similar substances may constitute "drugs."
FDA Notice,
¶43,707D.
FDA Form 1572 draft information guidance published
— A draft guidance intended to assist institutional review boards (IRBs),
clinical investigators, and sponsors involved in clinical investigations of
investigational drugs and biologics in completing the Statement of Investigator
form (Form FDA 1572) was issued by the FDA. It is titled "Information
Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently
Asked Questions—Statement of Investigator (Form FDA 1572)." The
agency developed the draft information sheet guidance in response to numerous
questions from the research community regarding Form FDA 1572, such as when
the form needs to be completed and signed by the investigator, how to best
complete the various blocks within the form, and when the form might need
to be updated.
FDA Guidance,
¶310,545.
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