FDA Policy/General
Federal Register proposed rule: FDA has proposed to amend its medical product “intended use” regulations to describe the types of evidence relevant to determining whether a product is intended for use as a drug or device, including whether an approved or cleared medical product is intended for a new use.
Drugs
Facing a 150-day deadline to respond, FDA has denied without comment specific requests made in a Taiho Oncology petition received 4/28 concerning its Lonsurf (trifluridine and tipiracil) tablets. The response says the petition asked FDA to: * refrain from filing or approving any ANDA or 505(b)(2) application
Drugs
An FDA drug safety communication says the agency is requiring an update to the Boxed Warning and requiring class-wide labeling changes for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions to help improve their safe use. An agency statement says the drugs are
Drugs
FDA has accepted and granted priority review for a Pfizer sNDA for Xalkori (crizotinib) for treating pediatric patients with relapsed or refractory systemic anaplastic large-cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK) positive. The agency granted breakthrough designation for the ALK-positive ALCL indication 5/2018. If the
FDA Policy/General
A day after news broke that FDA is expected to issue a guidance this week laying out tougher new standards for an emergency use authorization (EUA)of a Covid-19 vaccine, commissioner Stephen Hahn appeared on Capitol Hill to reassure lawmakers and the public that a transparent science- and data-
FDA Policy/General
Federal Register notice: FDA has determined that Carmel Biosciences’ Prexxartan (valsartan) oral solution, 20 mg/5mL and 80 mg/20 mL, were not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the if all other legal and regulatory requirements are met. Prexxartan
FDA Policy/General
FDA commissioner Stephen Hahn and CDC director Robert Redfield 9/23 dismissed notions that a “deep state” operates within their agencies intent on damaging president Trump’s reelection bid. Trump and his political ally and HHS chief spokesman Michael Caputo have recently advanced this conspiracy theory. Caputo is on a
Drugs
A 3/10-3/17 FDA inspection at the HNC Products drug manufacturing facility in Clinton, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/10 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a
FDA Policy/General
The U.S. House has passed two bills having wide implications for FDA in supporting continuous pharmaceutical manufacturing and combating counterfeit medical devices. HR 4866, “National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019,” was introduced by Reps. Frank Pallone (D-NJ) and Brett Guthrie (R-KY) and
FDA Policy/General
Federal Register notice: FDA has corrected a 7/29 final rule requiring electronic submission of certain postmarketing safety reports for approved new animal drugs and providing a procedure for requesting a temporary waiver of the electronic submission requirement. Table 2 of the final rule published with errors and this document
Drugs
FDA has sent a complete response letter (CRL) to Hikma Pharmaceuticals on its ANDA for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder). The company describes the letter as containing “minor” issues and says it is working closely with the agency to quickly address
Drugs
FDA has granted priority review for the BLA submitted by Bristol-Myers Squibb and bluebird bio for idecabtagene vicleucel (ide-cel), an investigational B-cell maturation antigen-directed chimeric antigen receptor T-cell immunotherapy for treating adults with multiple myeloma who have received at least three prior therapies, including an
Devices
FDA is launching a Digital Health Center of Excellence within CDRH. An online announcement says the launch “is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, software as a medical device, wearables when used as a medical
Drugs
A 2/26-3/10 FDA inspection at Coupler Enterprises, Warrington, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/15 Warning Letter says specific violations were: * failing to inspect the packaging and labeling facilities immediately before use to assure that all drug
Drugs
FDA says it intends to amend its medical product intended use regulations that describe the types of evidence relevant to determining whether a product is intended for use as a drug or medical device under the law and implementing regulations, including whether an approved or cleared medical product is intended
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Draft Guidance for Cannabidiol. The document provides product-specific recommendations on the information and data needed to demonstrate bioequivalence to support ANDAs for cannabidiol oral solution. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced an 11/19 public meeting Webcast entitled “CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses.” The meeting is scheduled to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids. Presentations will
Drugs
FDA is alerting health care professionals and patients to a recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Co. due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. The albuterol inhalers are used to treat
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Coupler Enterprises, Warrington, PA (9/15): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Coupler failed to inspect the packaging and
Biologics
FDA is expected to issue a guidance later this week laying out tougher new standards for emergency authorization of a Covid-19 vaccine. The Washington Post says the new standards “will make it exceedingly difficult for any vaccine to be cleared before Election Day.” The Post article says the new
Devices
FDA has granted Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System. The grant follows completion of the company’s SCOUT (Spineology Clinical Outcomes Trial) study. “OptiMesh is a unique mesh device that expands in three dimensions, enabling surgeons to perform interbody fusion procedures through
Drugs
FDA has added content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated document includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application