Responding to the challenges clinical trial investigators are facing with getting informed consent during the COVID-19 pandemic, the FDA is making its Mystudies app available as a free platform. Offered under the name COVID Mystudies, the app allows investigators to obtain informed consent securely from patients when face-to-face contact isn’t possible or practical because of COVID-19 control measures. Before using the app, investigators will provide their informed consent documents to the COVID Mystudies team so they can be added to the app. Investigators will be able to review the informed consent within the app before using it in their trials. Investigators still must have institutional review board review and approval of the informed consent document and process, the FDA said.
In its latest effort to modernize the nearly 40-year-old Orange Book, formally known as the Approved Drug Products with Therapeutic Equivalence Evaluations publication, the FDA issued a draft question-and-answer guidance to help sponsors more effectively use the listing of approved generic and branded small-molecule drugs. The guidance discusses the content and format of the Orange Book, petitioned abbreviated new drug applications, the movement of drug products between the active and discontinued sections, and drug product and patent listings. In addition to the draft guidance, the agency opened two dockets to get input on how stakeholders and the public use the Orange Book and on what patents should be included. Docket No. FDA–2020–N–1069 seeks information on who uses the Orange Book, how and why they use it and how it can be improved to further drug competition. In Docket No. FDA–2020–N–1127, the FDA is asking for comment on whether it should expand the types of patents listed in the Orange Book beyond those related to drug substance, formulation or composition, and method of use. In opening the docket, the agency noted the increasing complexity of drugs, including drug-device combination products, complex delivery systems and associated digital applications. Thus, it is examining whether more clarity is needed about the types of patents it lists and whether there would be advantages in also listing other types of patents, such as those related to the device component of the drug product, a risk evaluation and mitigation strategy or digital apps. Comments on the guidance and the two dockets should be submitted by Aug. 31, 2020.
The FDA is seeking comment on practical steps and successful approaches to establishing a rare disease clinical trial network. The project is part of the agency’s Rare Disease Cures Accelerator, which is aimed at providing a more cooperative approach and common platforms to support rare disease characterization, development of standard core sets of clinical outcome assessments and endpoints relevant to rare conditions, and conduct of clinical trials in rare disease populations. In its request for input, the agency said it is interested in understanding what work is being done and what needs to be done to improve the design, conduct and completion of rare disease clinical trials. It noted that because of the small size of rare disease populations and the global occurrence of rare conditions, the networks needed to support drug development would have global reach and operations. Comments should be submitted to Docket No. FDA-2020-N-0837 at regulations.gov by July 31, 2020, according to a notice in Monday’s Federal Register.
A diabetes drug is the latest being recalled due to unacceptable levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen. Apotex Corp., part of Toronto-based Apotex Inc., is recalling all lots of its metformin hydrochloride extended-release tablets, USP 500 mg, after the FDA notified the company that one lot showed NDMA levels above the acceptable daily intake limit. Apotex stopped selling the product in the U.S. in February 2019, so only a limited supply is on the market, according to the FDA. NDMA-related recalls began two years ago when testing showed excessive levels of NDMA in generic blood pressure drugs containing valsartan or other sartans. Since then, the impurities have been found in ranitidine drugs used to treat heartburn and in nizatidine, an ulcer drug. Apotex recalled its over-the-counter ranitidine tablets in September 2019 after the FDA and other regulators raised the alarm about NDMA in both brand and generic ranitidine products.
Citing the “extraordinary situation” caused by the pandemic, the U.S. Patent and Trademark Office (USPTO) said it’s waiving the prohibition of the electronic filing of initial patent term extension applications until further notice. In addition, the USPTO is waiving the requirement for two additional copies of the initial extension application when it is submitted via the agency’s electronic filing system.
The American Association for Cancer Research (AACR) is partnering with The Mark Foundation for Cancer Research on a new grant program that will allow researchers to explore cancer biology more holistically. The partnership will provide $750,000 over three years through Science of the Patient grants to support research projects that will advance the understanding of cancer initiation, progression, treatment and survivorship. “In cancer research, we typically drill down to the molecular level for insights, but to truly transform our knowledge of the disease, we also need to step back and look at the whole patient,” said Michele Cleary, CEO of The Mark Foundation. Proposals to explore novel concepts that have the potential to affect clinical practice are particularly encouraged, according to AACR. Letters of intent for the grants will be accepted through July 20, 2020.