This article compares real-world evidence (RWE) and postmarket surveillance (PMS) data collected outside of a randomized, controlled, clinical trial. Real-world data (RWD) include individual patient data points such as complaints and anecdotal findings. The recent explosion in RWD collection has led to new challenges in RWD evaluation globally. Solutions are rapidly evolving to analyze these relatively random data points for scientifically valid purposes. This article disc...

Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior policy advisor for global compliance in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).   Higgins outlined some of the consequences that can occur when these variables are not controlled, includin...

A proposed reorganization of the Food and Drug Administration Office of Regulatory Affairs (ORA) will “modify things significantly” for foods as well as medical products and is expected to be finalized this fall, said Janet Woodcock, the agency’s principal deputy commissioner at a 2 March webinar sponsored by the Alliance for a Stronger FDA.   Woodcock offered an update, yet few specifics, on the proposed restructuring of ORA, first floated on 31 January. Key among the...

Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards has recently been affected by the legal requirement for the FDA to standardize the regulatory approach to ophthalmic products whose components are considered devices. The agency communicated the update through a guidance outlining the phase-i...

Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process ...

The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.   The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous ...

The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market if companies refuse to allow inspections of their facilities without adequate justification. Under current FDA policy, only drugs can be deemed adulterated if FDA inspectors are barred at the door.   The draft align with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices also be dee...

This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions – EU, UK, US, China, and other regions of the world – to improve the role of nutrition in support of optimal care for patients. Part 1 covers general principles governing FSMPs, use of FSMPs in community and hospital settings, common regulatory challenges, opportunities for category growth, and considers a multistakeholder initi...

The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.   These tools are not intended to replace onsite inspections but inste...

Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...

A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.   The International Coalition of Medicines Regulatory Authorities (ICMRA) announced the pilots on 24 June. The group said that the pilots were prompted by its July workshop which “highlighted the need for more convergence on CMC [chemistry, manufac...

CHICAGO – The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting ...