medical device fda label expert witness cv

MEDICAL DEVICE FDA LABEL EXPERT WITNESS CV SERIES

Town Hall forums have been used to great success since the start of the pandemic in CDRH to accelerate the development of new IVD products.

MEDICAL DEVICE FDA LABEL EXPERT WITNESS CV SERIES

This move is likely to ease the pressure on their overburdened review staff by creating an organic reference Q&A for industry without having to create and iterate a new series of guidance documents. The solution that OTP has reached is to address what are very likely to be common industry problems in a public setting. OTP has spent years communicating industry-wide problems on an individual basis. With the explosion of new gene therapy investigations in recent years, these meetings with industry have become a proverbial black-hole of OTP’s time, energy, and reviewer resources. The standard practice is for FDA to engage with companies on an individual basis through formal meetings and deliver directed feedback to specific sponsor questions. When on the bleeding edge of new product development, it can be hard to know ahead of time what the agency is looking for in terms of CMC information.

The restructuring of OTAT into a “super-office” will increase its review capabilities, and enhance expertise on new cell and gene therapies. Wilson Bryan opened this new forum for direct agency feedback by describing the transformation of OTAT into the Office of Therapeutic Products (OTP). Our attorneys can serve as FDA litigation advisers, expert witnesses, or manage FDA document production and FOIA requests.On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. The FDA Atty firm offers a litigation support in any FDA matter. The due diligence involves understanding what disclosures were made and whether the information is adequate for the purpose. Here questions of claims compliance, misbranding, classification and related topics can prove key to these cases.įDA litigation advisers are also needed to examine documents in securities and acquisitions litigation. It is not uncommon for similar names or concepts to emerge and engage in litigation. The competition in food, beverage, and supplements is immense. Testimony or opinions can be given on a wide range of topics for trademark or patent litigation, product liability, securities and other litigation. Understanding how the product was approved and how the company complied with post-market responsibilities can prove pivotl in building a winning strategy.įDA litigation advisers can also serve as expert witnesses. Plaintiff’s counsel is typically challenged by overcoming the presumption of safety associated with a device or drug approval. This is commonly the case in product liability litigation and class action lawsuits.

The guidance provided on compliance sheds light on culpability and duty of care. A FDA litigation adviser can help answer these and other questions for the litigation team. For example, a product liability suit involving the injury from a drug or medical device could raise questions of FDA approval, classification, off-label use, and investigations into FDA sources indicating when problems were first reported.

Medical device fda label expert witness cv