Medical Research Law & Policy Report® Index-Summary

MARYLAND

– Nanotechnology funding cuts approved, 530
– Private-sector stem cell research funding considered, 159
– Stem cell research funding hike proposed by governor, 89; funding approved by General Assembly, 330; grant cuts approved, 530

MASSACHUSETTS

– Community benefits of nonprofits, Boston mayor wants probe, 23
– Conflicts of interest

– – Fees for covered firms due Jul. 1, 433
– – Gifts to MDs, limits criticized, 54; compliance problems predicted, 90; medical organizations moving conferences out of Boston, 91; final rules adopted, 204
– – Hospital network to limit interaction with industry, 285

– High-risk biological agents, ban proposed in Cambridge, 531
– Life sciences initiative, applications accepted, 90

MEDICAL DEVICES

– Aseptic isolators, attorneys' fees awarded in defamation claim (S.D. Ind.), 585
– Hospital research costs, HHS improperly excluded, 554
– In vitro diagnostic devices (IVDs)

– – Direct-to-consumer genetic test likely to be considered IVDs, 626
– – Guidance issued by FDA, 614

– Investigational device exemption, FDA offers draft guidance, 328
– Knee and hip replacement registry

See LEGISLATION, FEDERAL, HR 2813

– Knee injury treatment, FDA did not follow established protocol in review and clearing, 703
– Lab safety standards unenforced by FDA, watchdog group says, 154
– Premarket notification, FDA program under scrutiny, 671
– Unauthorized trial of medical device, execs plead guilty (E.D. Pa.), 534
– Waxman (D-Cal) wants probe of FDA clearance of knee device, 404

MEDICARE

– Comparative effectiveness research urged, 84
– Fraud, copays by research sponsors, CMS withdraws FAQ, 40
– FY2010 teaching hospital payment cuts opposed, 394
– Warfarin, Medicare to cover clinical trial, 560

MENTAL HEALTH

– Minn. considers ban on clinical trial participation by subjects in mental health commitment process, 127; bill signed, 374

MICHIGAN

– Biobank for newborns, state plans, 432
– Infection control at hospitals evaluated, 530
– Stem cell research tracking and reporting considered, 565
– Univ. of Mich. failed to show that patent issues were more than incidentally implicated in sex discrimination complaint (E.D Mich.), 143

MINNESOTA

– Human subject protection, state considers ban on clinical trial participation by subjects in mental health commitment process, 127; signed, 374
– Physician gift ban, bill withdrawn, 286
– Privacy, families sue over Health Dep't storage of newborn blood and DNA, 203

MISCONDUCT IN RESEARCH

See FRAUD AND ABUSE