A newsletter for those involved in clinical trials. Published 20 times a year by Canary Ltd

FDA updates

The following articles on this topic have been published in CRAdvisor (CRA) – the year, issue number and starting page number for each are listed below:

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2007  
CRA 2007; 183:4 FDA proposes new rule for experimental drugs.
CRA 2007; 185:4 Strengthening US drug safety.
CRA 2007; 185:5 Flexible trials pose regulatory questions.
CRA 2007; 186:4 HHS updates guidelines on event reporting requirements in USA.
CRA 2007; 186:6 Sponsors fail to run promised post-marketing studies.
CRA 2007; 186:6 EU drug review times.
CRA 2007; 187:3 FDA and US industry tighten up on pharmacovigilance.
CRA 2007; 189:8 US bill to enforce requirements for expansion of trial registry.
CRA 2007; 190:1 New guidance: US adverse event reports.
CRA 2007; 191:1 New FDA guidance on computerised systems.
CRA 2007; 192:1 FDA guidance on the supervisory responsibilities of investigators.
CRA 2007; 192:2 New FDA guidance on "computerized systems used in clinical investigations".
CRA 2007; 192:4 FDA advises on adverse event reporting.
CRA 2007; 193:5 FDA releases draft guidance on receipt dates for electronic submissions.
CRA 2007; 194:3 New FDA guidance reminds investigators of supervisory responsibilities.
CRA 2007; 194:8 EU-US regulatory co-operation.
   
2006  
CRA 2006; 163:10 Utah Medical in FDA legal dispute.
CRA 2006; 164:4 New FDA guidance on Data Monitoring Committees.
CRA 2006; 165:1 FDA issues guidance on efficiencies in early clinical drug development.
CRA 2006; 165:7 FDA's new drug safety initiative.
CRA 2006; 166:2 FDA issues guidance on efficiencies in early clinical drug development.
CRA 2006; 166:7 FDA and AdvaMed Workshops on Postmarket Safety of Devices.
CRA 2006; 167:2 Standard clauses for data transfer are underused says EC report.
CRA 2006; 167:4 US initiative to improve cancer therapy through development of biomarkers.
CRA 2006; 167:8 FDA workshop on new technology for counterfeit drugs.
CRA 2006; 168:1 Centralised IRB review for multicentre trials.
CRA 2006; 168:5 Q & As on the FDA's Drug Safety Oversight Board.
CRA 2006; 168:7 Predictive safety testing consortium to share information.
CRA 2006; 168:8 International co-operation on medicines regulation intensified.
CRA 2006; 168:8 FDA unveils priority projects for medical product development.
CRA 2006; 169:4 FDA finalises guidance on centralised IRB review.
CRA 2006; 169:6 FDA issues draft guidance on patient-reported outcome instruments.
CRA 2006; 169:8 Cooperation on medicines regulation intensified.
CRA 2006; 170:8 Non-clinical safety evaluation of drug or biologic combinations.
CRA 2006; 171:7 France and Sweden link with FDA.
CRA 2006; 171:7 Drug firm registration status.
CRA 2006; 171:8 NIH report: changes in US ageing.
CRA 2006; 172:8 FDA abandons Phase I GMP plans.
CRA 2006; 172:8 FDA enforcement discretion.
CRA 2006; 173:2 FDA issues draft guidance on US trials involving children as subjects.
CRA 2006; 173:8 FDA criticised by GAO.
CRA 2006; 174:3 New FDA initiative aims to modernise clinical trial regulation and bioresearch monitoring.
CRA 2006; 174:7 Uptake of electronic patient-reported outcomes: challenges ahead.
CRA 2006; 175:6 FDA meetings on the up.
CRA 2006; 175:8 R&D productivity doldrums.
CRA 2006; 176:12 US PhRMA responds on BIMO.
CRA 2006; 177:6 IRB ownership and conflicts of interest.
CRA 2006; 178:8 FDA reviews draft guidance and announces public hearing on emergency research.
CRA 2006; 179:4 FDA reviews draft guidance on emergency research.
CRA 2006; 180:2 IOM releases report on US drug safety.
CRA 2006; 180:8 cGMP quality systems guidance.
CRA 2006; 180:8 FDA revises guidance on drug interaction studies.
CRA 2006; 181:8 Consent in emergency research.
CRA 2006; 182:11 Former FDA Commissioner pleads guilty to financial conflict of interest.
   
2005  
CRA 2005; 143:7 OTC manufacturers more likely to be inspected by FDA.
CRA 2005; 145:6 Deficiencies in FDA post-marketing safety surveillance highlighted.
CRA 2005; 148:6 FDA puts X-SCID trials on hold.
CRA 2005; 148:6 US marshals seize products.
CRA 2005; 148:6 New procedures for review of cancer therapies.
CRA 2005; 148:8 FDA accused of being toothless.
CRA 2005; 149:5 New FDA guidance on centralised IRB review.
CRA 2005; 149:8 Revised FDA advice on electronic transmission of ICSRs.
CRA 2005; 150:1 FDA invites pharmacogenomic data submissions.
CRA 2005; 150:3 FDA issues final risk minimisation guidances.
CRA 2005; 150:8 FDA describes 2004 accomplishments.
CRA 2005; 152:2 New draft guidance on clinical trial endpoints for approval of cancer drugs and biological agents.
CRA 2005; 156:7 FDA re-tooling of field force.
CRA 2005; 157:7 FDA updates Vigibase.
CRA 2005; 157:7 FDA rulemaking clarified.
CRA 2005; 158:6 FDA loses key staff member over "politicised" decision.
CRA 2005; 160:2 FDA issues guidance on race and ethnicity data in clinical trials.
CRA 2005; 160:8 FDA Commissioner resigns.
   
2004  
CRA 2004; 124:4 FDA requires e-filing of labelling.
CRA 2004; 126:3 FDA revises guidance on IND exemptions for approved cancer treatments.
CRA 2004; 126:7 FDA guidance documents.
CRA 2004; 126:7 Submissions to Clinical Trials Data Bank.
CRA 2004; 126:7 Clinical evaluation of weight-control drugs.
CRA 2004; 126:7 Access to therapy outside the trial setting.
CRA 2004; 128:6 FDA approved 35 new medicines in 2003.
CRA 2004; 128:8 TUFTS report claims the FDA will be under pressure.
CRA 2004; 129:7 EU and US harmonise approval times.
CRA 2004; 130:5 A guide to the FDA rulemaking process.
CRA 2004; 130:6 FDA supports more access to information.
CRA 2004; 130:7 FDA guidance on botanical drugs.
CRA 2004; 130:8 FDA to hold meeting on 21 CFR Part 11.
CRA 2004; 131:4 FDA set to speed up approval of innovative breakthroughs.
CRA 2004; 133:6 FDA to revise regulations on foreign studies.
CRA 2004; 134:3 FDA set to speed up approval of innovative breakthroughs.
CRA 2004; 134:7 FDA awards for two Swiss inspectors.
CRA 2004; 135:6 More FDA guidance on acceptability of foreign data.
CRA 2004; 136:11 FDA is changing attitude on the acceptability of foreign studies.
CRA 2004; 137:3 FDA proposes establishment of IRB database.
CRA 2004; 137:4 Long jail sentence and big fine for cheating US investigator.
CRA 2004; 137:12 FDA opts for standardised format for trial data.
CRA 2004; 138:1 US guidance on the use of clinical holds following misconduct at site.
CRA 2004; 140:3 The use of clinical holds following investigator misconduct.
CRA 2004; 141:7 FDA regulation of pharmaceutical manufacturing.
CRA 2004; 142:1 FDA may not strictly enforce 21 CFR Part 11.
CRA 2004; 142:10 Statistics relating to FDA inspections.
CRA 2004; 142:11 FDA has final say on use of independent consultants.
CRA 2004; 142:11 New FDA guidance on the quality of gene therapies in IND studies.
CRA 2004; 142:11 FDA moves to strengthen safety programme for marketed drugs.
   
2003  
CRA 2003: 102:2 Mandatory paediatric testing in the USA?
CRA 2003; 102:6 New combination vaccine protects against five childhood diseases.
CRA 2003; 102:6 FDA restricts import of certain drugs
CRA 2003; 102:6 New FDA office for overview of combination products.
CRA 2003; 103:1 FDA debars researcher and study nurses.
CRA 2003; 103:6 FDA halts gene therapy trials using retroviral vectors.
CRA 2003; 104:4 FDA issues guidance on collection of race and ethnicity data.
CRA 2003; 104:7 FDA launches initiatives to increase the number of approved products.
CRA 2003; 105:6 FDA influenced by industry?
CRA 2003; 106:5 FDA discusses steps for re-starting gene therapy trials.
CRA 2003; 106:5 Regulation of pharma-manufacturing.
CRA 2003; 108:3 FDA asks HHS Inspector General to investigate FDA-sponsored clinical trial.
CRA 2003; 109:5 FDA proposes rule to improve safety.
CRA 2003; 109:7 Alzheimer's research update.
CRA 2003; 113:6 FDA publishes first annual report on post-marketing studies.
CRA 2003; 113:6 NCI and FDA collaboration.
CRA 2003; 114:6 FDA discusses paediatric drug safety under Best Pharmaceuticals for Children Act
CRA 2003; 114:6 Studies on patients with impaired hepatic function.
CRA 2003; 114:7 Paediatric expert to sit on CDRH panel.
CRA 2003; 114:7 First nasal mist flu vaccine.
CRA 2003; 114:7 Company receives massive penalties.
CRA 2003; 114:7 First biological drug for allergy-related asthma.
CRA 2003; 114:7 Protease inhibitor for treating HIV infection.
CRA 2003; 114:7 No Paxil for under-18s.
CRA 2003; 116:6 FDA draft guidance on pre-market assessment of paediatric medical devices.
CRA 2003; 116:7 Pediatric Research Equity Act approved.
CRA 2003; 116:8 FDA presents paediatric drug safety report.
CRA 2003; 117:6 FDA given money to research generics.
CRA 2003; 117:6 US Senate approves Pediatric Rule.
CRA 2003; 118:6 EMEA and FDA exchange confidentiality agreements.
CRA 2003; 119:1 Lawsuit may force FDA's hand on cancer treatments.
CRA 2003; 119:4 Calls for changes in US law governing dietary supplements.
CRA 2003; 120:7 US Federal Trade Commission charges Swiss-based company.
CRA 2003; 121:6 EMEA and FDA provide first parallel advice.
CRA 2003; 121:6 Regulation of dietary supplements.
CRA 2003; 121:8 Guide for blood collection fatalities.
CRA 2003; 122:7 FDA's common submission standards.
   
2002  
CRA 2002; 81:6 Foreign firms require US agent.
CRA 2002; 82:6 New guidance on data monitoring committees.
CRA 2002; 82:8 FDA creates drug safety committee.
CRA 2002; 82:8 Software validation materials.
CRA 2002; 84:3 FDA encourages CTD submissions.
CRA 2002; 87:6 FDA review times for new molecular entities.
CRA 2002; 88:6 Updated FDA product fact sheets online.
CRA 2002; 91:1 US Department of Health proposes new rules to expose IRB shopping.
CRA 2002; 91:6 Some products can be approved for emergency responses without human testing.
CRA 2002; 91:6 Trials on life-threatening diseases.
CRA 2002; 91:6 Data monitoring committees.
CRA 2002; 95:1 FDA requirement for electronic submissions.
CRA 2002; 96:5 FDA Special Agent receives fraud prevention award.
CRA 2002; 96:5 FDA proposes IND exemptions for oncology drugs.
CRA 2002; 99:6 Portal page debuts with information for FDA-regulated industry.
CRA 2002; 99:6 Compliance programme news.
CRA 2002; 99:6 New FDA Commissioner.
CRA 2002; 99:6 Review of bioethics: players and issues.
CRA 2002; 101:1 FDA publishes Notes for Guidance on maintaining electronic records.
   
2001  
CRA 2001; 60:5 Legal implications for the adverse event reports.
CRA 2001; 60:5 Dating the FDA 1572.
CRA 2001; 60:6 Latest on paediatric studies.
CRA 2001; 62:6 US 'Orange Book'.
CRA 2001; 63:5 FDA want greater compliance to 21 CFR Part 11.
CRA 2001; 63:6 FDA approval times.
CRA 2001; 64:1 FDA get tough on uncorrected violations.
CRA 2001; 64:6 Implications for AE reports.
CRA 2001; 66:6 Sponsors react to FDA sham controls.
CRA 2001; 68:1 FDA has no requirement for Helsinki 2000.
CRA 2001; 69:1 FDA releases interim rule for paediatric trials.
CRA 2001; 69:1 New guidance on financial disclosure issued by the FDA.
CRA 2001; 71:6 Early meetings with FDA improve approval chances.
CRA 2001; 72:1 FDA a servant of the industry?
CRA 2001; 72:8 FDA able to impose monetary penalties for informed consent violations?
CRA 2001; 73:2 FDA investigates death of healthy volunteer.
CRA 2001; 73:6 FDA issues guidance on safety pharmacology studies.
CRA 2001; 74:2 FDA guidance for Part 11 still unavailable.
CRA 2001; 75:6 FDA urged to waive parental consent for minors.
CRA 2001; 75:6 FDA release approval times.
CRA 2001; 75:6 FDA guidance agenda.
CRA 2001; 75:6 Women in trials.
CRA 2001; 76:1 Company official jailed for fraud.
CRA 2001; 76:6 FDA needs consumers.
CRA 2001; 77:1 FDA releases Part 11 Guidance.
CRA 2001; 77:3 FDA Drug Centre establishes new office.
CRA 2001; 77:6 'Emerging majority' identified.
CRA 2001; 78:2 Towards compliance with CFR 21 Part 11.
CRA 2001; 78:6 Research into prescriptions during pregnancy.
CRA 2001; 78:6 Industry concerned by FDA inspectors.
CRA 2001; 79:6 Good news for trial subjects.
CRA 2001; 79:6 PDFs unacceptable for e-submission.
CRA 2001; 80:1 Medication errors harm patients.
CRA 2001; 80:7 FDA and sponsor-investigator research.
CRA 2001; 80:8 FDA establishes GCP office.
   
2000  
CRA 2000; 41:1 Can trial data be sent to the FDA? 
CRA 2000; 41:5 FDA acts against illegal online pharmacies.
CRA 2000; 41:6 FDA enters flu treatment debate.
CRA 2000; 41:6 History of CDER.
CRA 2000; 46:3 FDA enforcement: recalls, detentions, prosecutions and arrests.
CRA 2000; 46:6 Consent for emergency research.
CRA 2000; 52:1 Gene therapy death causes review of regulations.
CRA 2000; 52:6 FDA to impose clinical holds on studies that exclude women.
CRA 2000; 56:6 FDA purge on illegal on-line drug sales continues.
CRA 2000; 57:2 Reporting adverse events on medical devices to the FDA.
CRA 2000; 59:1 FDA yet to issue new guidance on financial disclosure.
CRA 2000; 59:6 FDA to do systems based audits.
   
1999  
CRA 1999; 19:4 Millennium bug may affect validity of FDA submissions.
CRA 1999; 25:1 FDA and industry to create research institute.
CRA 1999; 26:1 FDA financial disclosure rules now in effect.
CRA 1999; 32:2 Interim analysis and bias.
CRA 1999; 35:1 FBI investigate recent drug approval in the USA.
CRA 1999; 35:4 FDA and electronic records.
CRA 1999; 35:5 FDA launches targeted product information pilot.
CRA 1999; 35:5 ODE IV pre-IND consultation program.
CRA 1999; 36:1 Federal scrutiny for gene therapy after death.
CRA 1999; 38:6 Financial disclosure help.
CRA 1999; 38:6 NDA approval times improve.
CRA 1999; 39:sup Financial disclosure by clinical investigators guidance for industry.
   
1998  
CRA 1998; 4:2 FDA tightens up on computerisation standards.
CRA 1998; 5:2 FDA version of ICH GCP guidelines is different from Step 4 document.
CRA 1998; 7:5 FDA news.
CRA 1998; 9:1 FDA introduces rules on financial disclosure.
CRA 1998; 14:1 Foreign non-IND studies and the FDA.
CRA 1998; 16:3 FDA working party on pregnancy labelling.
CRA 1998; 17:3 The FDA Modernization Act.
CRA 1998; 18:1 Data quality and CEE countries.
CRA 1998; 18:2 FDA cannot meet its enforcement obligations.

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