Medical Research Law & Policy Report® Index-Summary

SAFETY

– Avandia

– Clinical trials, FDA reporting rule, 612
– Contamination at Pfizer facility, jury award for fired scientist (D. Conn.), 206
– EHR and patient safety, 623
– Nanotechnology

– – FDA program

See LEGISLATION, FEDERAL, S 2942

– – Toxicity research urged, 224
– – White House panel raises issues, 224

– Radiation dosing, 80
– Safety Report Portal, FDA-NIH announces, 345
– Sentinel Initiative, FDA safety monitoring system, 50; Harvard Pilgrim contract award, 51
– Tissue sample management, HHS panel FAQs, 189

SECURITIES

– Harvard Scientific misstatements (7th Cir.), 615
– Sequenom genetic studies, class action settlement (S.D. Cal.), 86

SPAIN

– Patient-oriented innovation pushed, 218

STEM CELL RESEARCH

– California

– – Acceptable research material rule, In Brief, 113
– – Amended rules, 458
– – Bond measure, 760
– – Consolidating CIRM requirements, 83
– – Cooperation with Wis., 412
– – Donation of embryos, 113
– – Funding bills approved by panel, 180
– – Grants

– – – Early transaction awards, 694
– – – Investigator incentives, 286
– – – Status of institutions, CIRM report, 83

– – Loan, guidelines approval, 113
– – Outreach to industry, 790
– – Oversight of CIRM, Senate bill, 146; action suspended, 316; approved, 561
– – Pact with Md., 728
– – Strategic review, 626

– Clinical trials

– – Clearance from FDA, 750
– – Enrollment, 651
– – Trial enrollment, 651

– Definition of human embryo stem cells, NIH, 134
– EU, stem cell bank services, no VAT exemption, 371
– Evaluating treatments, website, 375
– Funding

– – California

See California, this heading

– – First hESC line, approval recommendation, 74
– – Ill. grants, 254
– – Implementation

See LEGISLATION, FEDERAL, HR 6081, S 4808, S 3751, S 3766

– – Induced pluripotent stem cells, NIH grant, 77
– – Md. funding, 253
– – N.Y. funding, 220
– – Regenerative medicine financing, 647
– – Wicker opposes, 610

– Guidelines

– – Natl. Academies, 337
– – NIH guidelines challenged (D.C. Cir.), 397; enjoined (D.D.C.), 547; order stayed, 579; injunction lifted, 605

– Human study cleared by FDA, 479
– Md. pact with Cal., 728
– Medicare coverage, 517
– Okla. reporting rule, 84; system, 492
– Patents

– – Related patents analysis, 171
– – WARF patent invalid for obviousness (B.P.A.I.), 269

– Potential new treatments, testing on pluripotent stem cells, 248
– Registry, NIH adds 13 lines, 273; more lines added, 404
– Third-party gamete donor consent, 140
– Transplant coverage denial (D. Neb.), 211
– U.K. physician sanctioned, 630

SUPREME COURT, U.S.

– AIDS/HIV

– – Drug evaluation methods (rev grant), 685
– – Stanford AIDS therapy, rights assignment (briefs sought), 397
– – University patents and Bayh-Dole (briefs sought), 397

– Anthrax vaccine approval upheld (rev den), 136
– Cialis inventorship (rev sought), 658
– Nigeria, Trovan clinical trial injuries (brief filed), 368; (rev den), 401; limited discovery (S.D.N.Y.), 689
– Nuclear waste, interstate disposal compact between Ala. and N.C. (oral arg), 54; no liability for N.C., 377

SWEDEN

– Destruction of data by researcher, 731