In the health care field,regulatory compliance is everyone’s responsibility.Health care providers working in collaborationwithvariousstakeholders,from regulators to payers to patients, can enable better outcomes and more efficient processesthroughrobust compliance programs. ...
Once your manufacturing company fails safety inspection or your pharmaceutical facility ignores FDA regulations, it could lead to significant operational disruptions. Regulatory agencies may mandate immediate shutdowns until compliance is achieved; therefore, you have to halt production and delay crucial pro...
With deep expertise and experience in fraud and abuse counseling, we advise life sciences companies and healthcare providers of all sizes on the full spectrum of related matters — from structuring advice, to day-to-day compliance counseling, to developing, implementing, and auditing compliance progr...
, dovetailed with the release of the Health Over Wealth Act, aiming for increased transparency in PE investment in healthcare. On April 18, 2024, FTC, DOJ and HHS unveiled HealthyCompetition.gov, which allows anyone to submit a complaint for these agencies to review and investigate healthcare...
Other materials prove product safety and health function. For imported health food filing, besides the above documents, the following supplementary documents also should be submitted: Qualification certifying documents issued by government authorities or legal service agencies in the producing country (region...
The paper will also deal with the importance of the International Conference on Harmonization which has played a key role in bringing different regulatory agencies of the world to achieve the common goal of promoting globalization in healthcare. 2014, Asian Journal of Pharmaceutical and Clinical ...
Medical affairs –working together on communication strategies and presentation of clinical data to healthcare professionals and regulatory agencies Pharmacovigilance and safety –monitor and report adverse events to comply with post-market surveillance requirementsPush...
We also have substantial experience in relation to borderline products and mainstream cosmetic, food supplement and biocide products. We provide contentious and noncontentious advice side-by-side and have represented clients in many administrative law proceedings against regul...
Regulatory Agencies.Lists government regulatory agencies for medical care in the U.S. U.S. Agency for Health Care Research and Quality; U.S. Centers for Disease Control and Prevention; U.S. Occupational Safety and Health Administration.EBSCO_bspHealthcare Purchasing News...
Due to the enormous amount of information presented in a marketing application, agencies are encouraging applicants to submit applications electronically in required formats that can facilitate their regulatory review (for example, eCTDi for drugs and biologics).1,2 In Canada, for example, all premark...