FDA Policy/General
Federal Register notice: FDA is providing notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s BLA: AbbVie, Inc., et al. v. Boehringer Ingelheim Intl. GMBH et al (17-cv-01065 and filed on Delaware
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Technical Considerations for Additive Manufactured Medical Devices” that is intended to provide initial thoughts on technical issues specific to 3-dimensional (3D) printing. The document also covers testing and characterization for final finished devices fabricated using additive manufacturing. To view
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.” The document modifies the agency’s current policy on IDE categorization, which assists CMS in determining whether or not
FDA Policy/General
Attorney Glenn Lammi, chief counsel for Washington Legal Foundation’s (WLF) legal studies division, writes in an online WLF Legal Pulse that FDA is once again appearing in the courts to argue for uniform, national regulation of consumer products. “In the past decade, private litigants and state officials have increasingly
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hangzhou Facecare Cosmetics Co. Hangzhou, Zhejiang, China (11/17): FDA inspected the firm in June and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to
FDA Policy/General
Federal Register notice: FDA has announced six modifications the agency is making to its FDA-Recognized Consensus Standards listing for use in premarket reviews. The listing is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Seven entries have been
FDA Policy/General
Federal Register notice: FDA has proposed to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device (product code MBU), into Class 2 (special controls) subject to 510(k) clearance. FDA is also identifying the proposed special controls that it believes are
FDA Policy/General
Federal Register notice: CDER has announced its intent to accept proposals from pharmaceutical companies interested in participating in the Office of Pharmaceutical Quality’s Staff Experiential Learning Site Visit Program. Firms can submit a site visit proposal in electronic or written form by 2/2/2018. To view the notice,
FDA Policy/General
Panel to Review Ciprofloxacin Dispersion for Inhalation NDA Federal Register notice: FDA announces a 1/11/2018 Antimicrobial Drugs Advisory Committee meeting. to review an NDA for ciprofloxacin dispersion for inhalation. 12/01/2017 Meticorten Not Withdrawn Due to Safety/Effectiveness: FDA Federal Register notice: FDA determines that Schering’s
FDA Policy/General
Federal Register notice: FDA has announced a 1/11/2018 Antimicrobial Drugs Advisory Committee meeting. Panel members are expected to discuss an Aradigm Corp. NDA for ciprofloxacin dispersion for inhalation, indicated for treating non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has determined that Schering’s Meticorten (prednisone) tablets were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to continue to approve ANDAs that reference the product as long as relevant legal and regulatory requirements are met. The action
FDA Policy/General
Federal Register notice: FDA has announced the withdrawal of 68 ANDAs from multiple applicants. The application holders have notified the agency that the drug products are no longer marketed and requested that the approvals be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced its intent to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices used in a healthcare setting and worn by healthcare personnel during procedures
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” It describes study designs for generating data that supports both 510(k) clearance and CLIA-waived categorization. Use of the Dual 510(k) and
FDA Policy/General
Federal Register notice: FDA has announced a 1/26/2018 public hearing on its approach to evaluating the safety and efficacy of nicotine replacement therapy products, including how they should be used and labeled. The hearing is intended to obtain input on the appropriate study designs and methods for evaluating
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for patent extension purposes for Wellstat Therapeutics’ Xuriden (uridine triacetate), indicated for treating hereditary orotic aciduria, is 8,494 days. Of this, 8,254 days occurred during the testing phase and 240 days occurred during the approval phase. To
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for patent extension purposes for Relypsa’s Veltassa (patiromer sorbitex calcium), indicated for treating hyperkalemia, is 2,844 days. Of this, 2,478 days occurred during the testing phase and 366 days occurred during the approval phase. To view
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document updates FDA’s thinking on the appropriate use of comparable performance between a waived user and a
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency is taking a new approach to tobacco and nicotine through an initiative to lower nicotine in cigarettes and find new ways to support development and regulation of nicotine replacement therapy (NRT) products that help smokers quit. In an online post with CDER director
FDA Policy/General
A new Public Citizen report reviewing the 457 rulemakings the Trump administration has listed as withdrawn says that FDA, with 26 withdrawn regulations, had the most of any HHS agency. Five of the 26 were designated as “economically significant,” expected to have an economic impact of at least $100 million.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Export of FDA-Regulated Products: Export Certificates OMB Control Number 0910-0498.” The collection is authorized by the FDA Export, Reform, and Enhancement Act of 1996 that was designed to ease restrictions on exporting unapproved pharmaceuticals, biologics,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” The document discusses the circumstances where packages and homogenous cases of product not labeled with a product identifier shall be exempted and grandfathered from certain drug