As part of a push to reduce administrative burdens, the US Food and Drug Administration (FDA) on Wednesday finalized guidance on an optional streamlined submission process for determining the risk of an investigational in vitro diagnostic (IVD) in a clinical trial where an investigational IVD is being co-developed with an oncology investigational drug. The submission process, first proposed in draft guidance in April 2018 , is meant to help sponsors determine if an IVD...

The US Food and Drug Administration (FDA) recently released tables that can be included in submissions for new drug and biologic applications to provide information regarding the bioanalytical methods for pharmacokinetic assessments. “The templates in this guidance are applicable to bioanalytical procedures such as chromatographic assays (CCs) and ligand-binding assays (LBAs) that quantitatively determine the levels of drugs and their metabolites and therapeutic protein...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help sponsors design and conduct nonclinical studies for developing investigational enzyme replacement therapy (ERT) products. ERT products, which generally involve exogenously supplying the missing or defective protein, can treat an array of disorders resulting from inherited defective genes (e.g., Gaucher disease, Fabry disease, Pompe disease and mucopolysaccharidoses), FDA explains. The n...

The US Food and Drug Administration (FDA) on Monday published the second in a series of four guidance documents on patient-focused drug development, with this latest draft helping sponsors identify what is most important to patients with respect to their experience with disease burden and treatment. In determining what’s important, FDA recommends that sponsors use qualitative research methods, which can generate in-depth thoughts from patients in their own words through...

A section of the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and removed certain software functions from the definition of a medical device. In addition to drafting new guidance on clinical decision support software, the US Food and Drug Administration (FDA) on Thursday released final guidance explaining what digital health products are no longer devices and are no longer subject to FDA regulations. Examples of such...

Thanks to the FDA Reauthorization Act of 2017 (FDARA) , the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices. At the outset of the seven-page draft, FDA warns that it has concluded “that it is not feasible to describe and implement the electronic format(s) that would apply” to all the device submissions in one guidance document, so this g...

The US Food and Drug Administration (FDA) on Monday released new draft guidance explaining how sponsors can improve the design and conduct of medical device clinical investigations by using patient experience, perspectives and other relevant information. The 10-page draft mainly addresses four questions: What approaches might sponsors use to engage patient advisors (defined by FDA as those who have dealt with or are dealing with a particular condition but are not inv...

The US Food and Drug Administration (FDA) on Monday finalized guidance to assist in the clinical development of treatments for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The 11-page guidance, which finalizes a draft version from February 2018, includes information on general development, safety and effectiveness considerations, as well as specific effectiveness trial considerations. The guidance incorporates parts of a guidance put toget...

As part of work to implement the optional Safety and Performance Based Pathway for medical devices, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday issued four draft guidance documents identifying performance criteria and testing methodologies for certain devices within four class II device types. CDRH also released updated final guidance explaining the new pathway and to further clarify the information FDA wil...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a stay of agency action are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application. The final guidance comes as FDA in February explained its concerns to Congress that such petitions are often...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday updated its no-deal Brexit guidance for medical devices, adding a new section on the role of the “UK Responsible Person.” According to the guidance, the UK Responsible Person, who must be established in the UK, acts on behalf of a non-UK manufacturer to carry out tasks for the manufacturer, which include registering with the  MHRA  before a device is placed on the UK market. “Only a manu...

About a dozen drugmakers and industry groups recently offered their opinions on a revised US Food and Drug Administration (FDA) draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. The comments largely seek specific tweaks to the 23-page revised draft, which was released in July , although some of the comments also seek further clarity and new additions to the guidance. Indu...