News & Analysis as of

Good Clinical Practices

EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

by Hogan Lovells on

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation. The Draft Guideline updates the previous guideline on TMF that...more

INC Research Merges with inVentiv Health Creating a $7.4B Combined Entity

by Knobbe Martens on

According to press releases, INC Research Holdings, Inc. has agreed to merge with inVentiv Health, creating a combined company having an enterprise value of approximately $7.4 billion. The press release further notes that the...more

NEWSFLASH: What happens if you purchase a marketing authorisation then revoked for serious noncompliances with the Good Clinical...

by Hogan Lovells on

Transfer of a MA, its subsequent revocation and compensation for damages - What happens if you purchase a marketing authorisation and that is then revoked for serious non-compliances with the Good Clinical Practice...more

FDA Releases Revised Draft Guidance on the Distribution of Scientific and Medical Publications About Unapproved Uses: Guidance...

by King & Spalding on

On March 3, 2014, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (“Revised Draft...more

FDA Issues Revised Draft Reprints Guidance

by Ropes & Gray LLP on

On February 28, 2014, the Food and Drug Administration (“FDA”) released a revised draft guidance for industry entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“Revised...more

China Releases Vaccine Good Clinical Practices

by Ropes & Gray LLP on

On October 31, 2013, The China Food and Drug Administration (“CFDA”) promulgated a regulation titled Guiding Principles for the Quality Management of Clinical Studies on Vaccines (“Vaccine GCP”), with immediate effect. The...more

FDA Issues Proposed Rule Amending Regulations Regarding Acceptance of Data from Clinical Studies for Medical Devices

by King & Spalding on

On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices. The proposed rule would require that...more

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