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Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top priority” for FDA.  Based on these comments, FDA is clearly not giving up on monograph reform: FDA has long engaged in this effort, and we will continue to do so, working with all stakeholders and Congress to make clear that OTC monograph reform is a critical…
On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product.  Even as some of the details remain to be hashed out, the guidance makes clear FDA’s desire to minimize the burdens of obtaining a determination of interchangeability.  The guidance summarizes the important scientific considerations for demonstrating interchangeability, including:…
On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including sunscreens.  As FDA has previously explained, the guidance states that MUsT studies can identify the potential for the systemic exposure for a topically-applied active ingredient.  FDA believes that this information is necessary to determine whether additional safety studies are needed to support…
On 8 April 2019, the European Commission’s High-Level Expert Group on AI (“HLEG AI“) published its ethics guidelines for trustworthy artificial intelligence (the “Guidelines“). The Guidelines follow an earlier first draft in December 2018 and implement more than 500 comments received through an open consultation. The Guidelines aim to provide a framework for achieving “Trustworthy AI”: artificial intelligence that is (i) lawful, (ii) ethical, and (iii) robust. In particular, the Guidelines focus on offering guidance…
On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance.  The final guidance contains no significant substantive changes to the draft version, but here are a few interesting tidbits: FDA will respond to comments seeking clarification on the process for obtaining therapeutic equivalence evaluations in a forthcoming guidance document. FDA clarified that petitioned ANDAs are expected…
Cartels are by their nature hard to uncover and regulators rely – to a large part – on appealing to companies’ wallets. Immunity and leniency policies, by which regulators offer to whistleblowing companies full immunity or discounts from fines, have been around for a long time. An increasing number of regulators have now added another instrument to their cartel enforcement toolkit: the offering of financial incentives to lure individual employees to come forward and whistleblow…
On May 1, 2019, the National institute of Standards and Technology (NIST) announced a Request for Information (RFI) in the Federal Register regarding ongoing efforts to develop technical standards for artificial intelligence (AI) technologies and the identification of priority areas for federal involvement in AI standards-related activities. Responses to the RFI are due by May 31, 2019. The RFI comes in response to President Trump’s Executive Order to Maintain American Leadership in Artificial Intelligence, which…
Earlier this month, the Canadian government announced the appointment of Sheri Meyerhoffer as the first Canadian Ombudsperson for Responsible Enterprise (“CORE”). The position has been lauded as being the first of its kind in the world. This blog post considers a number of the key issues which are still to be ironed out before Ombudsperson Meyerhoffer begins her work in earnest.…
On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall, respond to an indication of a problem with a distributed product, and initiate a voluntary recall.  Overall, FDA emphasizes the importance of pharmaceutical, biotechnology, medical device, food, tobacco, and animal products firms having made…
The construction and further development of infrastructure is of crucial importance for society and a healthy economy. But protecting the environment and human rights has also come to the forefront of the global agenda. At times these two goals have been cast as mutually exclusive, but the financing community has recognized the imperative to harmonize developing modern infrastructure with preserving our natural habitat and upholding social standards. The majority of financing banks have for some…