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CCH NetNews™
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(July 29, 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
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regulations and court decisions that govern the
safety, effectiveness, purity, packaging and labeling
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plus expert analysis of all laws and regulations
governing the classification, approval, manufacture,
and marketing of all medical diagnostic, and
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Featured This Week:
CGMPs for phase 1 drugs amended, guidance released
— The FDA amended the current good manufacturing practice (CGMP) regulations
for human drugs, including biological products, to exempt most phase 1 investigational
drugs. The agency reasoned that human drug products intended for use in phase
1 clinical trials should be exempt they remain subject to statutory adulteration
requirements and because the FDA oversees these phase 1 trial drugs through
its existing investigational new drug applications authority.
FDA Order,
¶40,350D.
CPG for decomposing fish available; old CPG withdrawn
— A draft compliance policy guide (CPG) on fish decomposition provides
regulatory action guidance relating to the FDA's direct reference enforcement
policy, including a description of a two-class, pass/fail evaluating approach
for detecting the presence of decomposition by sensory or chemical analysis.
When the draft CPG is final it will replace withdrawn and revoked CPGs relating
to decomposition in fish and shrimp. Comments on the draft CPG are due by
September 16, 2008.
FDA Guidance,
¶330,388.
Immune globulin intravenous products: trial designs
— A guidance providing information on the design of clinical trials to
assess the safety, efficacy, and pharmacokinetics of investigational immune
globulin intravenous products when used as replacement therapy in primary
humoral immunodeficiency has been issued by the FDA. The document is intended
to assist sponsors in the preparation of the clinical/biostatistical and human
pharmacokinetic sections of a biologics license application and investigational
new drug application.
FDA Guidance,
¶320,384.
Ephedrine in dietary supplements ban
— A small entity compliance guide explaining the FDA's ban on ephedrine
alkaloids in dietary supplements is available to help small businesses understand
the regulation. The FDA issued the ban on February 11, 2004, finding that
dietary supplements with ephedrine present an unreasonable risk of illness
or injury under conditions of use recommended in labeling or under ordinary
conditions of use.
FDA Guidance,
¶330,386.
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