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The 3Rs Principles in Cosmetic and Self-care Industry: the Regulation that Prioritises Animal Welfare

biobide

With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.

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Ensuring Your Organization is Prepared for the Implementation of the EU Clinical Trial Regulation

PPD

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

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Article Periodic Thank You Swiss regulators align with EU on chemicals, biocides

Agency IQ

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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Article EMA Thank You What you need to know about the status of the proposed EMA fees regulation

Agency IQ

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog: Biosimilars

Citing to a 2004 Supreme Court case, Verizon Commc’ns., 398 (2004), Teva argued that Amneal has no cause of action under antitrust law because the Hatch-Waxman Amendments impose a new statutory duty on a company to cooperate with competitors and established a remedy for breach of that obligation. of Trinko, LLP , 540 U.S.

FDA 116
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Mary Lynne Hedley

Broad Institute

where she served as a director, president, and CEO prior to the acquisition of ZYCOS by MGI PHARMA in 2004. She did her postdoctoral training at Harvard University in the areas of immunology and gene regulation with Tom Maniatis and Jack Strominger. Prior to her role at MGI, she was a co-founder of ZYCOS Inc.,

Science 52
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DEA Regs Bulk Up with 2014 Anabolic Steroid Control Law Additions

FDA Law Blog: Biosimilars

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”).