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A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
On December 31, 2013, the CFPB published final rules implementing provisions of the Dodd-Frank Act, which direct the CFPB to publish a single, integrated disclosure for mortgage transactions, which included mortgage disclosure requirements under the Truth in Lending Act (TILA) and sections 4 and 5 of RESPA. As a result, Regulation Z now houses ...
An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most Laboratory Developed Tests have been regulated under this program. [3] In 2014 the FDA started a public discussion about regulating some LDTs. [4]
U.S. government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co may be linked to serious mental health problems for some patients, according to a ...
A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous jurisdiction over some area of human activity in a licensing and regulating capacity.
The Committee for Advanced Therapies (CAT) was established in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products (ATMPs) such as gene therapy, somatic cell therapy and tissue engineered products. It assesses the quality, safety and efficacy of ATMPs, and follows scientific developments in the field.
A musical inspired by viral Olympic breakdancer Raygun was shut down hours before it was due to open on Saturday, after lawyers representing the athlete threatened legal action, the show’s ...
By Joseph Ax, Helen Coster and James Oliphant (Reuters) - U.S. President-elect Donald Trump's vow to impose tariffs on China and Mexico unless they stem the flow of fentanyl and migrants across ...