Remanufacturing of Medical Devices Updated Guidance
Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and environments of use. […]
Regulation
Regulation
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including Coronavirus
Drug's Approval
FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency
The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment
Life Science Regulatory Compliance Firm Delivers Business Success Through Strategic Partnerships
J&JCC Group offers unprecedented success for clients navigating Regulatory Compliance during the COVID-19 Pandemic. Irvine, California, January 12, 2022, J&JCC
The FDA Intends to Publish a Pathway for CBD Products!
In the letter that the Food and Drugs Administration (FDA) issued on November 25, 2019, the agent issued 15 warning
FDA Intention to Develop A New Standard for Tobacco Products- Reduced Health Risk!
The Food and Drug Administration (FDA) has recently announced its intention to “explore clear and meaningful measures to make tobacco
Tobacco Products Labeling Compliance. Another Deadline is Approaching – August 10, 2018
Nicotine Addictiveness Warning Statement Beginning August 10, 2018, FDA will enforce a new nicotine warning Statement. Manufacturers and distributors cannot
FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal
Summary Letters to four companies follow initial request to JUUL Labs as part of an ongoing effort to address youth
Current Good Manufacturing Practices — An Overlooked Requirement with Far Reaching Consequences
A significant provision of the Family Smoking Prevention and Tobacco Control Act is the requirement for tobacco manufacturers to operate