Navigate Compliance Waters

Widler & Schiemann AG can provide you with innovative, creative and cost effective answers to your questions and needs in the areas of Clinical Quality Management. With our vast experience and extensive network in the industry and the regulators we are uniquely positioned to identify and provide the best solutions for you.

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  • 19 July 2019
  • 71
Why Industry Anticipates a ‘Cliff-Edge’ Scenario with EU MDR/IVDR
Manufacturers and the European Association of Notified Bodies alike face difficult decisions with the new
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  • 18 July 2019
  • 84
Regulations on Customized Medical Device Supervision and Management (Trial Version) in China
New regulations on customized medical devices in China
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  • 17 July 2019
  • 87
German Study Finds Most New Drugs Fail to Improve on Standard of Care
Germany’s Institute of Quality and Efficiency in Healthcare (IQWiG) finds there is no evidence of added benefit for more than half of the drugs the institute assessed from 2011-2017.
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  • 17 July 2019
  • 76
Risk Evaluation and Mitigation Strategies:
Modifications and Revisions Guidance for Industry
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  • 15 July 2019
  • 100
Population
Pharmacokinetics Guidance for Industry
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  • 15 July 2019
  • 103
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent
Pregnancy Guidance for Industry
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  • 30 June 2019
  • 125
One additional country to benefit from EU-US mutual recognition agreement for inspections
Germany Joins EU-US GMP Mutual Recognition Pact
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  • 30 June 2019
  • 141
Optimisation of Safety Data Collection
This guidance is being distributed for comment purposes only
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  • 30 June 2019
  • 153
ANDA Submissions — Content and Format of Abbreviated New Drug Applications
Guidance for Industry ensuring a complete, high-quality application submitted to FDA
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  • 30 June 2019
  • 97
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
This guidance document is being distributed for comment purposes only.
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  • 30 June 2019
  • 108
Research Investigational New Drug Applications – What You Need To Know
Similarities and differences in submission requirements for Commercial and Research IND
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  • 30 June 2019
  • 126
China publishes regulation on management of human genetic resources
New rules to regulate genetic research
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  • 30 June 2019
  • 184
Guidance Document: Pre-market Requirements for Medical Device Cybersecurity
Health Canada’s new premarket requirements on medical device cybersecurity came into effect
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  • 24 June 2019
  • 126
China to stipulate the accountabilities of Marketing Authorization Holder (MAH)
China released the “Revision of the Drug Administration Law of the People's Republic of China” for public comment
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  • 17 June 2019
  • 134
China to implement new regulation for on-site inspections at the clinical sites and manufacturing facilities
National Medical Products Administration (NMPA) released “Regulations for on-site inspections at the clinical sites and manufacturing facilities” for public comment
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  • 17 June 2019
  • 155
EMA Guideline on the quality requirements for drug-device combinations
Documentation expected for Drug-Device Combinations (DDCs)
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  • 17 June 2019
  • 108
FDA Report on Pharmaceutical Quality
Product Quality of Products marketed in the USA
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  • 17 June 2019
  • 125
RWD & RWE in FDA submissions
New Draft Guideline on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
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  • 07 June 2019
  • 115
ICH E8 under revision
The ICH Guideline “General Considerations for Clinical Trials” is under revision and has been issued for public comments
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  • 01 June 2019
  • 111
Significant advancements in global harmonization efforts at ICH’s largest biannual meeting to-date
Sixteen Members and twenty-eight Observers met in Amsterdam
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  • 21 December 2018
  • 514
China makes switch to faster approval system for imported drugs
NMPA and National Health Commission of China have established faster system to review and approve on urgently needed new drugs that have been approved in other countries
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  • 17 December 2018
  • 639
EMA eSource Direct Data Capture (DDC) qualification opinion issued
the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials
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  • 10 December 2018
  • 884
EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries
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  • 03 December 2018
  • 659
FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018
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  • 20 September 2018
  • 1539
EMA Draft questions and answers on Data Monitoring Committees issues
A Supplement to the CHMP Data Monitoring Committee Guideline
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  • 15 September 2018
  • 628
EMA on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
New Draft Guideline issued; consultation end date: July 2019
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  • 10 September 2018
  • 691
FDA Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
New FDA Guidance for Industry
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  • 05 September 2018
  • 622
New FDA Draft Guidance on Hematologic Malignancy and Oncologic Disease
Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
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  • 03 September 2018
  • 842
New FDA draft Guidance on Expansion Cohorts
Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
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  • 16 August 2018
  • 712
CNDA seeks feedback on latest GCP Regulation Draft
The Chinese National Drug Administration (CNDA) is looking for feedback by August 16, 2018
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  • 12 August 2018
  • 668
FDA Final Guidance for Industry: ANDA Submissions
Amendments to Abbreviated New Drug Applications under GDUFA
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  • 08 August 2018
  • 763
FDA Announces Two Initiatives on Quality Metrics Program Development
FDA is looking for feedback on their recent Quality Initiatives on Metrics
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  • 04 August 2018
  • 778
FDA Publishes List of Surrogate Endpoints Used in Drug Approvals
The list includes surrogate endpoints for approval of new drug applications
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  • 02 August 2018
  • 650
EMA Policy 70 submissions temporarily suspended as of 1 August
Phase 2 of EMA’s Business Continuity Plan soon to come into effect
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  • 28 July 2018
  • 636
Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
Publication of updated Q+As and practical guidance
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  • 21 July 2018
  • 742
Re-issuing of USFDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA (Biosimilar User Fee Act) Products
Comments are encouraged within 90 days of issuance
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  • 14 July 2018
  • 706
New FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Draft Guidance published for receiving comments within 60 days
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  • 07 July 2018
  • 685
Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
Agreement now operational between 14 EU Member States and FDA
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  • 20 June 2018
  • 616
Informed Consent for Pediatric Clinical Trials in Europe 2015 - Updated
Update from May 2018 detailing procedures in all member states
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  • 15 June 2018
  • 886
Pediatric investigation plans: questions and answers
Detailed guidance for sponsors applying for a pediatric investigation plan (PIP)
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  • 10 June 2018
  • 769
EMA draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice
EMA asks for comments on the new guideline by end of August 2018
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  • 06 June 2018
  • 826
USFDA issue new Guidance on Clinical Trial Imaging Endpoint Process Standards
Final Guidance for Industry effective April 2018
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  • 06 June 2018
  • 20288
US FDA issues Institutional Review Board (IRB) Written Procedures
Final Guidance for Institutions and IRBs effective May 2018
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  • 20 May 2018
  • 683
New EMA Draft Guideline on Clinical Evaluation of Vaccines
Comments can be sent in until 30th October 2018
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  • 16 May 2018
  • 711
Increasing oversight of API manufacturing through international collaboration
Report on the International API inspection program published
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  • 12 May 2018
  • 770
USFDA’s Revision 1 of the Special Protocol Assessment Guidance
In Effect: April 2018 – May 2020
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  • 08 May 2018
  • 689
New USFDA draft Guidance on in-vitro Diagnostics in Oncology Trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication
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  • 04 May 2018
  • 862
USFDA issue new draft Guidance on inclusion of pregnant women in clinical trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication
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  • 02 May 2018
  • 799
Beat Widler to moderate session at EFGCP Workshop 18th June 2018, London
Investigators meet Inspectors workshop by EFGCP in the light of ICH E6R2
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  • 20 April 2018
  • 931
New tracking tool for EMA’s relocation to Amsterdam
Tool gives transparent overview of main milestones and work stream deliverables
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  • 15 April 2018
  • 1101
USFDA’s Compliance Policy for Combination Product Post-Marketing Safety Reporting
Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
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  • 10 April 2018
  • 871
China’s NHFPC and CFDA to be downgraded amid ministerial reshuffle
The National People’s Congress officially approved plans for a ministry shakeup
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  • 05 April 2018
  • 873
CHMP adopts new Guideline on Good Pharmacogenomic Practice
The new guideline adopted by the CHMP will become effective on 1st September 2018
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  • 31 March 2018
  • 954
Clinical site initiation process remains lengthy and highly inefficient
New Tufts Center Report
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  • 26 March 2018
  • 1101
China’s CDE clarifies NDA dossier requirements
A wave of PD-1/PD-L1 mAb application pushes CDE to act
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  • 19 March 2018
  • 933
USFDA releases ICH Q11 guidance Q&A document
ICH Q11 Q&A document specifically about starting materials
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  • 12 March 2018
  • 884
USFDA releases ICH E6 R2 guidance
ICH guideline issued by the USFDA
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  • 05 March 2018
  • 909
USFDA BIMO Report presentation issued
The presentation gives an overview on the 2017 inspections and findings
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  • 04 March 2018
  • 1078
General Court confirms EMA approach to transparency
Three rulings clarify the scope of commercial confidentiality with regard to authorized medicines
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  • 19 February 2018
  • 1880
CFDA’s “Orange Book” launch marks new era of quality generics
Standards for generic products will ensure quality throughout the Chinese market
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  • 16 February 2018
  • 1079
CFDA moving to implement greater transparency over drug reviews
As full ICH member CFDA applies international standards
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  • 12 February 2018
  • 1382
CFDA applying ICH technical guidelines to drug filings, safety management
CFDA’s follow up on full ICH membership
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  • 08 February 2018
  • 1044
EMA surveys pharma companies on their preparedness for Brexit
Planning of regulatory steps needed to ensure medicines remain on EU market
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  • 04 February 2018
  • 964
Best Practices for Communication Between IND Sponsors and USFDA During Drug Development
Guidance for Industry and Review Staff
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  • 01 February 2018
  • 1103
Update: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Guidance for Industry and Food and Drug Administration Staff
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  • 20 January 2018
  • 1054
Small Business and Industry Assistance (SBIA) Documents in Chinese
US FDA provides SBIA documents in Chinese Translation
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  • 16 January 2018
  • 1292
US FDA Draft Guidance: The Least Burdensome Provisions - Concept and Principles
Draft Guidance for Industry and Food and Drug Administration Staff
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  • 12 January 2018
  • 1091
New US FDA Draft Guidance
Refuse to File: NDA and BLA Submissions to CDER
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  • 08 January 2018
  • 1058
Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
EMA and European Commission publish updated Q&As
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  • 04 January 2018
  • 2170
EMA adopts ICH guideline E17
ICH guideline E17 on general principles for planning and design of multi-regional clinical trials coming into effect in June 2018
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  • 31 December 2017
  • 986
Henk de Wilde joins Widler & Schiemann Ltd. as Managing Director
Henk de Wilde will join Widler & Schiemann Ltd. in Switzerland in January 2018
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  • 20 December 2017
  • 1135
USFDA Widens Scope of Navigator – Information Tool for Expanded Access
Two examples of the recent steps US FDA has taken in pursuit of improving their expanded access and orphan drug program
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  • 15 December 2017
  • 1408
New Edition of the International Compilation of Human Research Standards
2018 Edition now available
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  • 10 December 2017
  • 1115
New EudraVigilance system is live
Better safety monitoring for patients across Europe
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  • 05 December 2017
  • 6943
EU-US mutual recognition of inspections of medicines manufacturers enters operational phase
Major milestone is a testimony to mutual trust
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  • 01 December 2017
  • 1164
Xi Chen joins Widler & Schiemann Ltd. China as Managing Director
Ms. Xi Chen, MSc, MBA, has joined WS China with more than 20 years of industry experience
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  • 20 November 2017
  • 1236
China will allow private hospitals and other health related institutions
In his speech at the 19th National Congress of the CPC, President Xi Jinping emphasized the focus on “Healthy China”
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  • 16 November 2017
  • 1367
China now accepting Clinical Trial Data from other Countries
CFDA issued a new guideline announcing that for submissions clinical trial data from other countries will be accepted
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  • 12 November 2017
  • 1156
Updates on EMA Guideline on Good Pharmacovigilance Practice
Two of the updated Modules will become effective in November 2017
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  • 08 November 2017
  • 1014
New USFDA Draft Guidance on ANDA and 505(b)(2) Application
USFDA provides a guide for decision making whether to submit an ANDA or 505(b)(2)
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  • 04 November 2017
  • 1107
Update on USFDA Draft Guidance on REMS
Update on format and content of a REMS document – Revision of the 2009 Guidance
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  • 01 November 2017
  • 1417
Widler & Schiemann open China Office
Business license obtained, first employee hired
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  • 24 October 2017
  • 1214
New Pharmacovigilance (PV) Inspection Guide by Australian Health Authority
The Therapeutics Goods Administration (TGA) issued a new guidance for medicine sponsors on PV
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  • 18 October 2017
  • 1747
China FDA to issue catalogue of all drugs marketed in China
A Chinese Version of the USFDA’s “Orange Book” will be available soon
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  • 14 October 2017
  • 1169
Patient safety: Commission adopts acts on Good Manufacturing Practices for medicines
Focus on Marketed Products and Investigational Medicinal Products
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  • 08 October 2017
  • 1190
USFDA is advancing the Goals of the Orphan Drug Act
An Update from the USFDA Commissioner on the achievements to date
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  • 04 October 2017
  • 1253
Final USFDA Guidance on Real World Evidence and Medical Devices
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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  • 30 September 2017
  • 1367
New USFDA Draft Guidance on submitting REMS in SPL Format
Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Guidance for Industry
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  • 16 September 2017
  • 1628
The new 2017 Good Clinical Practice Q&A Guide is available!
Dr. Beat Widler is a reappearing author for this guide and member of the editorial board
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  • 12 September 2017
  • 1392
EMA Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: pediatric population
New Guideline open for comments until 13th October 2017
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  • 08 September 2017
  • 1159
EMA prepares for Brexit
Business continuity plan aims to preserve Agency’s ability to protect public and animal health
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  • 04 September 2017
  • 1294
SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION
RISK PROPORTIONATE APPROACHES IN CLINICAL TRIALS
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  • 01 September 2017
  • 2022
Dr. Oliver Hellstern invited as lecturer for Pharmacovigilance at ETH Zurich
Our PV Practice Leader, Dr. Oliver Hellstern, to teach about Pharmacovigilance at the University ETH Zurich
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  • 01 September 2017
  • 1084
Strengthening EU-US cooperation in medicine inspections
New commitment allows FDA to share full inspection reports with European Commission and EMA
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  • 20 August 2017
  • 1259
New ICH E19 Guideline in development on Optimisation of Safety Data Collection
Guidance on targeted approach to safety data collection
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  • 16 August 2017
  • 1243
EMA: Revised Guideline for Entry into Human
Guidance outlines strategies to identify and mitigate risks for trial participants
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  • 08 August 2017
  • 1182
USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details
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  • 04 August 2017
  • 1657
Update of the BIMO Guidance Manual
USFDA announced that a major revision BIMO manual was issued in April 2017 – Guidance for FDA staff
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  • 31 July 2017
  • 1286
New USFDA Draft Guideline on Electronic Records and Signatures
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 - Questions and Answers
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  • 22 July 2017
  • 1479
FDA Updates Part 11 Guidance for Clinical Trials to Include Mobile and Wearable Tech
Public Comments are invited until late August 2017
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