Medical Research Law & Policy Report® Index-Summary

SAFETY

– Biosafety a top issue for HHS IG in 2009, 57
– Drug-coat stents work better for elderly heart disease patients, 241
– Gene therapy trial death confirmed, 486
– Hemopure, proposed trial may be off, 12
– High-risk biological agents, ban proposed in Cambridge, Mass., 531
– Hypertonic saline trial stopped, 363
– Infection control at Mich. hospitals evaluated, 530
– Medical devices, lab safety standards unenforced by FDA, watchdog group says, 154
– Outlook 2009, post-marketing surveillance key issue, 5
– Pulmonary sickle-cell study halted due to safety issues, 518
– Sentinel Initiative at FDA, Senators want updates, 49; privacy concerns, In Brief, 430
– Seroquel maker accused of suppressing data on risks, 194
– Waxman (D-Cal) wants probe of FDA clearance of knee device, 404

SBIR (SMALL BUSINESS INNOVATION RESEARCH)

See RESEARCH AND DEVELOPMENT (R&D)

SECURITIES

– Celebrex, investors suit over alleged clinical study misrepresentations timely (3rd Cir.), 115
– Disclosure, thorough process needed to avoid SEC trouble, 321
– Prostate drug, investors accuse maker of false statements (S.D.N.Y.), 165
– Stem cell research misstatements alleged by SEC (W.D. Wash.), 623

SEROQUEL

– Antipsychotic maker accused of suppressing data on risks, 194

SILICONE GEL PROTHESES

– FDA approval after implantation, strict liability claim barred (M.D. Tenn.), 232

SOUTH KOREA

– Embryonic stem cell research

– – Jail sought for scientist, 594
– – Revival, panel delays, 122

SPAIN

– Nanotechnology research lab created, In Brief, 86
– Researchers moving to private sector, rules issued, 460

SPECIAL REPORTS

– CROs and outsourcing of development work, 344
– IRBs, ramifications of GAO probe, 294
– Pediatric products, obstacles to developing, 411

STEM CELL RESEARCH

– Adipose tissue stem cells, later contributors not inventors (Fed. Cir.), 515
– Allogeneic bone marrow transplant coverage denial upheld (6th Cir.), 698
– ALS trial, 21
– China collaborating with Cal., 712
– DeGette (D-Colo) to offer legislation, 74
– Funding

– – Castle (R-Del) and DeGette (D-Colo) plan bill, 650
– – Draft guidance from NIH limits funding to research with cells left over from fertility treatments, 307; limits raise concerns, 387; final guidance allows use of discarded embryos, 479
– – Federal funding ban lifted, 183; implications, Analysis & Perspective, 253; agencies urged to adopt NIH guidelines, 518
– – Increase

See LEGISLATION, FEDERAL, HR 873

– – Removing limits

See LEGISLATION, FEDERAL, S 487

– – State funding

See State developments, this heading

– – Top issue for 2009 at NIH, 9

– Generation of pluripotent stem cells, new method discovered, 147
– German collaboration with Cal., In Brief, 677
– hESC therapy trial for spinal cord injury cleared by FDA, 76
– License on stem cell transfers, claim for milestone payment rejected (W.D. Tenn.), 235
– Outlook 2009, top issue, 5
– Portugal creating public umbilical cord stem cell bank, 85
– Requests for stem cell lines, NIH accepting, 656
– South Korea, embryonic stem cell research revival, panel delays, 122
– State developments

– – California

– – – China collaboration pact signed, 712
– – – Exemptions, In Brief, 621
– – – German collaboration, In Brief, 677
– – – Grant funding approved, 249; public comment sought, 285; training grants and disease team funding approved, 463
– – – Intellectual property and revenues, In Brief, 23; regulations consolidated, 591
– – – Model science curriculum, state to promote, 621
– – – Obama order favored, 205
– – – Oversight criticized, 462

– – Maryland

– – – Hike proposed by governor, 89; funding approved by General Assembly, 330; grant cuts approved, 530
– – – Private-sector research, funding considered, 159

– – Mich. tracking and reporting considered, 565
– – Mo., challenge to funding rejected (Mo. Cir. Ct.), 87
– – N.M. bill to permit research defeated, 249
– – Oklahoma

– – – Criminal penalties for research, veto stands, 331
– – – Reporting rule, In Brief, 161; adopted, 496; system created, In Brief, 621

– – Tex. grant rules, In Brief, 621
– – Va. bioscience bill passed by Senate without stem cell amendments, 126; Assembly approves compromise, 158

– Univ. of Mich. consortium to create new stem cell lines, 203
– Universities, firms, advocates form coalition to push research, 520

STTR (SMALL BUSINESS TECHNOLOGY TRANSFER)

See RESEARCH AND DEVELOPMENT (R&D)

SUPREME COURT, U.S.

– Clinical trials

– – Arrhythmia treatment was not unauthorized experimental surgery (rev sought), 553
– – Trovan Nigerian clinical trial claims may be tried in U.S. (rev sought), 516

SWITZERLAND

– Biotech crop ban extended, 494