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CCH NetNews™
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(August 5, 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.
Order Your Subscription Today »
The Medical
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.
Order Your Subscription Today »
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Featured This Week:
Two-year fellowship program for new FDA scientists
— A two-year fellowship program aimed at attracting scientists, engineers
and health professionals to the FDA was just created. The FDA Commissioner’s
Fellowship Program will provide participants with advanced training in the
scientific analysis involved in the safety and regulatory decisions unique
to the agency’s mission. Applicants are being considered for the first
entering class of the program, which will begin in October 2008. The agency
is seeking physicians, microbiologists, chemists, statisticians, pharmacists,
biomedical engineers, nutritionists, veterinarians and other science professionals.
The FDA Commissioner’s Fellowship Program will include coursework and
extensive hands-on experience in FDA regulatory science including regulatory
review opportunities.
FDA News Release.
Food safety/security cooperative agreements available
— The FDA's Office of Regulatory Affairs, Division of Federal-State Relations,
will make cooperative agreements available for equipment, supplies, personnel,
training, and facility upgrades to Food Emergency Response Laboratory Network
(FERN) chemistry laboratories of state, local, and tribal governments. The
cooperative agreements will enable the analyses of foods and food products
in the event that redundancy and/or additional laboratory surge capacity is
needed by FERN for analyses related to chemical terrorism. These grants also
should expand participation in networks to enhance federal, state, local,
and tribal food safety and security efforts. The FDA will have substantial
involvement in the program including specific procedures and protocols for
the four project areas, as well as provide guidance on the specific foods
to be collected for analysis. The agency will purchase and deliver all major
equipment, which will remain the property of the FDA.
FDA Notice,
¶43,705D.
Sole source cooperative agreement granted to AFDO
— A sole source cooperative agreement was offered to the Association of
Food and Drug Officials (AFDO) by the FDA to provide funding over a three
year period to support a special project cooperative agreement program. The
cooperative agreement would require AFDO to update and maintain the FDA Directory
of State and Local Officials and to update the AFDO document “State
Food Safety Resource Survey (2000)” by providing funding for additional
personnel, equipment and supplies to support activities related to these projects.
The cooperative agreement also would require updates to the AFDO survey including
information on recall and foodborne illness investigations.
FDA Notice,
¶43,706D.
SAFER Meat, Poultry, and Food Act of 2008 introduced
— Senator Sherrod Brown (D-OH) introduced the “SAFER Meat, Poultry,
and Food Act of 2008” to amend the Meat Inspection Act, the Poultry
Products Inspection Act, the Egg Products Inspection Act, and the Food, Drug,
and Cosmetic Act to provide for improved public health and food safety through
enhanced enforcement. The bill would establish a system of notification, nondistribution,
and recall of all adulterated or misbranded foods. When a person, other than
a household consumer, has reason to believe that any food transported, stored,
distributed, or otherwise handled by the person is adulterated or misbranded
and may present a threat to public health, the person would be required to
immediately notify the FDA. Upon notification of the problem all firms that
transported, stored, distributed, or otherwise handled the food would be afforded
an opportunity to voluntarily: (1) cease distribution of the article; (2)
notify those transporting, distributing, or selling the article to immediately
cease; (3) recall the article; (4) provide notice to all persons that store,
distribute, handle, transport, or sell the article; and (5) notify state and
local public health officials. If these voluntary actions are not taken in
an appropriate time period, the HHS Secretary could order that distribution
be immediately ceased and relevant parties be notified, and then the Secretary
could may take possession of the article, as well as notify state and health
officials.
S. 3267, 110th Cong., 2d Sess. (2008),
¶200,106.
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