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FDA Law Update : FDA Regulation Lawyer & Attorney : Sheppard Mullin Law Firm : Food & Drug Administration Product Regulations
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Recent Updates
- Update on Tobacco Warning Letters
- FDA Announces Proposals for Biosimilars User Fees and Performance Review Goals
- Safe-Harbor Provision of Hatch-Waxman Act Does Not Protect Post-Approval Research Activities
- Rights to Compensation for use of Biospecimens: OHRP and FDA Clarify that Waivers of Rights in Informed Consents are not "Exculpatory"
- Institute of Medicine Report: Dead on Arrival
- Generic Drug Manufacturers And Failure To Warn: What duty is there after Pliva v. Mensing?
- Sunscreen in the Spotlight: FDA Illuminates New Sunscreen Regulations
- A MATRIXX Revolution, Part II: Supreme Court affirms Ninth Circuit's holding that life science companies cannot rely on a statistical significance standard when deciding whether adverse event reports are material for the purpose of securities disclosures
- FDA Announces Its Plan For Changes to the 510(k) "Approval" Pathway
- President Obama Signs New Expansive Food Safety Law
- E-CIGARETTES GET A "SMOKING" BREAK: D.C. Circuit Clarifies Scope of FDA's Authority Over E-Cigarettes
- IRS Guidance On New Excise Tax On Branded Pharmaceutical Companies: Filing Due January 21, 2011
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