FDA Policy/General
Comment Period Reopened on Metered Dose Inhaler Guide Federal Register notice: FDA reopens the comment period for its “Metered Dose Inhaler and Dry Powder Inhaler Drug Products — Quality Considerations; Draft Guidance for Industry.” 10/30/2020 Comment Period Extended on E-Data Files guide Federal Register notice: FDA extends the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 11 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Devices
The Western Michigan District Court has sentenced Roger D. Beyer to 57 months in federal prison for his involvement in a conspiracy to commit healthcare fraud and 12 months concurrently for the adulteration of medical devices. Beyer previously owned and operated Urological Solutions of Michigan, a mobile medical practice providing
Biologics
Regeneron Pharmaceuticals says it will temporarily stop enrolling patients requiring high-flow oxygen or mechanical ventilation in REGN-COV2 antibody cocktail treatment trials for Covid-19 because of a potential safety signal and an unfavorable risk/benefit profile at this time. The enrollment hold was based on a recommendation from
Drugs
FDA has released a revised guidance on Providing Regulatory Submissions in Electronic Format — Standardized Study Data. The document and technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data. The guidance revises the types of submissions that are exempted
Drugs
FDA is seeking to advance efforts associated with its Cell and Gene Therapy Program (CGTP) and Digital Health Program, according to FDA summaries of meetings with industry on negotiating the reauthorization of the Prescription Drug User Fee Act. The agency has proposed to “enhance resources for the existing CGTP in
FDA Policy/General
CDER Office of Prescription Drug Promotion (OPDP) director Tom Abrams has retired effective 10/23. Abrams spent 27 years at FDA, 20 of them at the helm of OPDP. Advertising and Promotion Policy Staff head Catherine Gray is serving as acting director. She has over 20 years of experience, including
Devices
Medtronic has agreed to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce a South Dakota neurosurgeon to use certain Medtronic products. The company also agreed to pay an additional $1.11 million to resolve allegations that it violated the
Drugs
Tricida says it was surprised by comments made by representatives of the CDER Division of Cardiology and Nephrology at a 10/20 end-of-review conference on its investigational drug veverimer. The drug is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney
Biologics
FDA has entered into a Cooperative Research and Development Agreement with Emulate, Inc., to enable multiple studies across FDA Centers in priority research areas, including programs to evaluate Covid-19 vaccines and understand human response against SARS-CoV-2. Emulate says that under the agreement the agency will use a
Devices
Attorney Michael Kasser (Hogan Lovells) says that the use of nitinol by medical device manufacturers “significantly increases the amount of bench testing that will be required to obtain marketing clearance.” In an online post, Kasser says a recently finalized FDA guidance on medical devices that contain nitinol details the corrosion
Drugs
A 2018 symposium panel with researchers from FDA, Johns Hopkins, and two private companies say the design and analysis of clinical studies play critical roles in evaluating and characterizing heterogeneous treatment effects. A special issue paper in the journal Pharmaceutical Statistics says researchers “can do more or better at understanding
FDA Policy/General
Federal Register notice: FDA announces an 11/19 virtual public meeting on reauthorizing the Biosimilar User Fee Act (BsUFA) for fiscal years 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the review process for biosimilar biological products. The current legislative authority for BsUFA expires 9/20/
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products. The document provides guidance about the nonclinical information FDA recommends to support development and approval of such products, including electronic nicotine delivery systems intended for smoking cessation and related chronic
Devices
FDA says Baxter has issued an urgent device correction to reinforce safety information on cleaning practices for all Sigma Spectrum infusion pumps. The 10/28 notice says that deviations from the specified cleaning methods may impair infusion pump functionality and performance. The company says it communicated the information to customers
Drugs
CDER researchers say that timely development of product-specific guidances, including those for complex generic drugs, along with prioritizing complex generic drug research, may facilitate ANDA submissions and promote generic drug price competition. A CDER Regulatory Science Impact Story post describes Center research into the factors that may predict the
Drugs
FDA is pitching a plan to enhance its Model-Informed Drug Development (MIDD) activities under the next iteration of its Prescription Drug User Fee Act (PDUFA) program, which is up for renewal 9/2022. During a recent FDA/Industry PDUFA subgroup negotiation meeting on regulatory decision tools, the agency discussed
Drugs
FDA has reached a five-year agreement with SomaLogic to evaluate the utility of large-scale analysis of proteins (proteomics) for identifying biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar to a reference biologic. The company says it will collaborate with FDA to identify circulating pharmacodynamic
Devices
CDRH will be seeking a boost to its resources as it negotiates the reauthorization of the Medical Device User Fee Act (MDUFA) program. During a 10/27 public meeting on reauthorizing the user fees, FDA commissioner Stephen Hahn acknowledged the resource strain from the current Covid-19 emergency on the
FDA Policy/General
The Justice Department has filed a civil complaint in a California federal court seeking a permanent injunction against Med-Pharmx and two individuals to prevent them from manufacturing and distributing animal drugs under conditions that fall short of the minimum regulatory requirements to ensure safety and quality. A Justice Department
Drugs
FDA has published a guidance, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products, to give sponsors recommendations on the nonclinical information to support the development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. The document
Drugs
Four stakeholders are praising the FDA draft guidance on evaluating cancer drugs in patients with central nervous system (CNS) metastases and offering suggested changes. Bristol-Myers Squibb says the draft guidance is intended to provide clarity on study procedures and data requirements to support a label claim for benefit to