September 15, 2014

Biotechnology, Food & Drug Administration FDA News

The National Law Review includes articles impacting the biotech and cleantech fields addressing: licensing and patent issues, intellectual property due diligence, litigation and tax. Content is also included addressing: greenhouse gas (GHG) regulation; mandated emissions reduction legislation; NEPA and CEQA claims, common law nuisance litigation; acquiring and selling emission offset and emission reduction credits and acid rain allowances under the United States Clean Air Act, SCAQMD RECLAIM and other air credit programs.

Date Title Organization
15
Sep
340B Federal Drug Pricing Program September Update: Self-Disclosures McDermott Will & Emery
13
Sep
Judge Requires PhRMA To Initiate New 340B Orphan Drug Lawsuit to Challenge Interpretive Rule Covington & Burling LLP
13
Sep
Looking Towards the Future of Pharmaceuticals in Africa Covington & Burling LLP
12
Sep
National Institute of Standards and Technology (NIST) Issues Draft Report Enumerating Risks and Protections to Consider When Evaluating Mobile Apps for Your Enterprise Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
11
Sep
FutureGen Receives EPA Permits for Underground Injection Greenberg Traurig, LLP
11
Sep
FDA Focuses on Sex-Specific Data in Medical Device Clinical Trials Covington & Burling LLP
11
Sep
FDA Publishes “Purple Book” for Biologicals/Biosimilars Schwegman, Lundberg & Woessner, P.A.
11
Sep
Indefiniteness After The Supreme Court Nautilus Decision – A Very “Delicate Balance” Schwegman, Lundberg & Woessner, P.A.
11
Sep
Court of Federal Claims Stays Decision Requiring Commercial Item Contractor to Comply with Non-Commercial Practices Covington & Burling LLP
10
Sep
Trouble Ahead For On-the-Job Post-Accident Drug Testing? Jackson Lewis P.C.
10
Sep
Ariosa Diagnostics v. Isis Innovation Limited: Final Written Decision (Motion to Amend) IPR2012-00022 Drinker Biddle & Reath LLP
9
Sep
FTC Brings its First Post-Actavis Suit re: Pharmaceutical Patent Litigation Covington & Burling LLP
9
Sep
FDA Issues Draft Guidance Regarding Controlled Correspondence from Generics Manufacturers Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
9
Sep
Decision Requiring Commercial-Item Suppliers to Comply with Non-Standard Terms under the Federal Acquisition Regulation (FAR) Is Stayed Pending Appeal at Federal Circuit Covington & Burling LLP
8
Sep
Wage & Hour Claims: A Look Back on the First Half of 2014 Gilbert LLP
5
Sep
Australia: Cancer Voices v Myriad Opinion Affirmed Schwegman, Lundberg & Woessner, P.A.
5
Sep
Telehealth and Health IT Policy: Considerations for Stakeholders Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
3
Sep
Government Issues New Rules for Religious Employers, But Health Plans, Third Party Administrators (TPAs), and Pharmacy Benefits Managers (PBMs) are still on the Hook to Provide Contraceptive Coverage Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2
Sep
EU Court Of Justice Further Clarifies Definition Of Medicinal Products – And Raises New Questions Covington & Burling LLP
2
Sep
China Issues Multiple Final Rules and Proposals to Implement Recent Revisions to its Core Medical Device Regulation Covington & Burling LLP

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