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NTP Director Turns Spotlight on Endocrine Disruptors
March 20, 2012By Ricardo Carvajal –
Linda Birnbaum, Director of the National Institute of Environmental Health Sciences and the National Toxicology Program, published an editorial discussing the most recent evidence that certain environmental chemicals, including suspected endocrine disruptors such as BPA, “can have effects that would not necessarily be predicted from their effects at high doses” – referred to as the “low dose hypothesis.” As the editorial puts it, “the question is no longer whether nonmonotonic dose responses are ‘real’ and occur frequently enough to be a concern; clearly these are common phenomena with well-understood mechanisms.” The upshot is that “chemicals with hormonal activity can have effects at external doses that are often considered safe by the regulatory community.”
With regard to BPA specifically, FDA is expected to announce later this month whether the agency will act to amend or rescind BPA’s approved food additive uses – a move compelled in part by a lawsuit filed by the Natural Resources Defense Council. It will be interesting to see whether evidence of nonmonotonic dose responses plays any part in FDA’s decision.
REMINDER: HP&M is hosting FDA Appeals – Improving Your Odds of Success: Trends, Expectations, Strategies, a webinar on March 21, 2012, 12:30 – 2:00 p.m. ET. Click here to register.
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- GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program March 29, 2024
- FTC Continues to Rage Against Device Patent Listings in the Orange Book March 27, 2024
- FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts March 26, 2024
- Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024
- Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference March 22, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized