Header graphic for print
Focus on Regulation

Tag Archives: Clinical Trials

Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures (MAPP) outlining the Office’s policy goals, roles, and responsibilities with respect to financial disclosures in NDAs, BLAs and NDA/BLA supplements.

Personalised Medicines at the top of the European Agenda

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published. The workshop discussed the views of patients, healthcare professionals and payers regarding personalised medicine. During the workshop future challenges and related actions, that should be taken regarding personalised medicine, were identified. The challenges

California Tries the “Right to Try” Act — FDA’s Expanded Access Regulations Remain in Force

On September 27, 2016, California Governor Jerry Brown signed into law the so-called “Right to Try Act” (AB-1668) (the “RTA”), which allows qualifying patients to request from manufacturers unapproved drugs, biologics, or medical devices that have successfully completed FDA-sanctioned Phase I clinical trial(s). In general terms, this law allows a manufacturer of an investigational drug,

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients.

European Court invalidates transfer of clinical data from the EU to the U.S through the Safe Harbor Framework

The Court of Justice of the European Union declares invalid the European Commission’s Safe Harbor Decision and its implications on the transfer of clinical data to the U.S On 6 October 2015, the Court of Justice of the European Union (“CJEU”) ruled that the European Commission Decision on the adequacy of the EU-U.S Safe Harbor

NIH Proposes Significant Expansions and Modifications to Requirements for Clinical Trial Registration and Results Disclosure on the ClinicalTrials.gov Data Bank

On Friday the National Institutes of Health (NIH) published an extensive proposed rule, intended to clarify and expand the requirements for submission of clinical trial registration and results information to the ClinicalTrials.gov data bank. See 79 Fed. Reg. 69,566 (Nov. 21, 2014). The rulemaking proposes to add a new Part 11 to Title 42 of the CFR to implement the statutory requirements set forth in section 402(j) of the Public Health Service Act (PHSA). Section 402(j) had been added to the statute by the Food and Drug Administration Amendments Act of 2007 (FDAAA).