Tighter Route: FDA Will Require Randomized Controlled Trials (RCTs) for CAR T-Cell Therapy Approval
The US Food and Drug Administration’s (FDA) Center for Biologic Research and Evaluation (CBER) has announced a significant shift in its regulatory approach for the approval of Chimeric Antigen Receptor (CAR) T-Cell therapies. Top agency officials indicate that, generally, the use of Randomized Controlled Trials (RCTs) will now be required to support new approvals in cancer treatment. This decision marks a transition from single-group studies (based only on response rate) to comparative trials with survival or time-to-event endpoints. The new stance aims to ensure that the benefits of these innovative therapies are measured with the highest standard of scientific evidence.
Clarity and Truth in Advertising: FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars
The US Food and Drug Administration (FDA) has finalized important guidance on the promotional labeling and advertising of reference listed drugs (RLDs), biosimilar products, and, crucially, interchangeable biosimilar products. The primary goal of this document is to ensure that all promotional communications about these products are accurate, truthful, and non-misleading. The publication fulfills a legal requirement (Biosimilar User Fee Amendments of 2022 – BsUFA III) and aims to address industry questions, establishing clear standards for presenting scientific data and information about interchangeability, a key concept for the adoption and success of the biosimilars market.
Navigating Regulatory Processes a Governmnet Reopens
Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.
The Pharmaceutical Industry Calls for Expansion of the FDA’s PreCheck Program
Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.
Health Canada Continues to Actively Monitor Supply of Medical Devices
Health Canada’s role in managing medical device shortages in Canada. It explains how the government continuously tracks and updates the list of devices in short supply, ensuring transparency and quick responses to potential shortages. By working closely with manufacturers, importers, and healthcare providers, Health Canada aims to stabilize the supply chain through regulatory adjustments and proactive policies.
Modifications to Container Closure Systems: Glass Vials and Stoppers
The FDA is providing this guidance to compile recommendations for the appropriate reporting categories and the content of post approval change submissions from various FDA guidance documents.
US FDA publishes Permanent Accreditation System Conformity Assessment Program
In September 2023, the US FDA issued regulatory updates, to the guidance on the Innovative Devices Program and preliminary guidance on medical devices associated with weight loss.
The U.S FDA Announces Pilot Program for Medical Device Submission with Health Canada
Overview On January 2023, the FDA announced that it has partnered with Health Canada to launch a joint eSTAR pilot. The pilot will allow medical device manufacturers to submit a premarket notice submission to FDA and Health Canada simultaneously. Introduction The eSTAR is an interactive PDF form that helps guide applicants through the medical device […]
How Cosmetic companies can stay complaint online during the COVID-19 Pandemic
The pandemic has produced new obstacles for all businesses including the cosmetic industry. the pandemic has produced a shift from shopping in stores to shopping online. the online platform is new media to many businesses and with it brings its own obstacles such as regulation requirements that differ by country.
The FDA Prepares for the Fourteenth Annual Meeting International Cooperation on Cosmetics Regulation.
The FDA announces on March 3rd that they hold a public meeting regarding the 14th International Cooperation on Cosmetics Regulation (ICCR)- to be held on April 14, 2020.
Regulation of vaping products in Canada
The Canadian government has established a regulatory framework for vaping products. As the incidence of vaping increases among the population, the government continues an aggressive campaign to lower and prevent interest of youths and adults who do not smoke tobacco.