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CCH NetNews™
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(June 3, 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:
CMS will share Medicare Part D datamining info with FDA
— The FDA's “Sentinel Initiative,” which will permit the
agency to immediately access Medicare Part D information on the postmarket
safety of prescription drugs, will take effect on June 27, 2008, due to a
Centers for Medicare and Medicaid Services regulation that allows the data-mining
(73
Federal Register 30664, May 28, 2008). The FDA's use
of Medicare Part D drug adverse event information, as well as similar information
from the Veteran's Administration, the Department of Defense and certain organizations,
will fulfill the Food and Drug Administration Amendments Act of 2007's (FDAAA)
mandate to the FDA to develop such an electronic system to improve postmarket
drug safety.
HHS News Release ¶43,683D.
Detoxification and maintenance patient limits increased
— A qualifying medical practitioner, whether working individually or in
a group practice, may offer maintenance and detoxification treatment to 30
patients at any one time, and certain qualifying practitioners may treat up
to 100 patients at any one time, under a Drug Enforcement Administration (DEA)
rule change that exempts such a practitioner from registering separately as
a Narcotic Treatment Program. The change removes the requirement that limits
to 30 the number of patients that could receive maintenance or detoxification
treatment by an individual physician or a group practice. The rule finalizes
a September 20, 2007 proposal, for which the DEA received one favorable comment.
The rule change will become effective on June 23, 2008.
DEA Order,
¶40,345D.
Anti-HBc assay for requalification method of blood donor pool
— A draft guidance providing information on recommendations about deferred
donors to establishments that collect human blood or blood components has
been issued for comment. Entitled “Guidance for Industry: Requalification
Method for Reentry of Blood Donors Deferred Because of Reactive Test Results
for Antibody to Hepatitis B Core Antigen (Anti-HBc),” the draft document
gives recommendations on a requalification method or process to reenter deferred
donors into a donor pool based on a determination that the previous tests
that were repeatedly reactive for anti-HBc were falsely positive and that
there was no evidence of infection with Hepatitis B virus (HBV). The availability
of a licensed HBV nucleic acid test and the improved specificity of anti-HBc
assays led to the FDA's recommendation of this new requalification method.
FDA Guidance,
¶320,381.
Allogeneic pancreatic islet cell products; draft guidance
— A draft guidance providing recommendations to manufacturers, sponsors,
and clinical investigators involved in the transplantation of allogeneic pancreatic
islet cell products for clinical investigations of the treatment of type 1
diabetes mellitus was published. Entitled “Guidance for Industry: Considerations
for Allogeneic Pancreatic Islet Cell Products,” the draft guidance
provides assistance by identifying the types of data and information obtained
during investigational new drug studies that may be helpful in establishing
the safety, purity, and potency of a biological product in a biologics license
application (BLA). The draft guidance, however, is not intended to identify
all of the product, preclinical, and clinical data that may be needed to successfully
support a BLA.
FDA Guidance,
¶320,382.
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