Drugs
The Justice Department says Gilead Sciences will pay $97 million to resolve allegations that it violated the False Claims Act by illegally using a foundation as a conduit to pay the copays of thousands of Medicare patients taking the firm’s Letairis pulmonary arterial hypertension drug. A department statement says
Drugs
In an abrupt break from decades of prior policy, FDA and HHS announced late 9/24 a final rule that allows FDA-authorized programs to import certain prescription drugs from Canada if specific conditions to ensure the importation poses no additional risk to public health and safety. A final guidance
Drugs
Novartis Gene Therapies says that based on an FDA recommendation it will undertake a pivotal confirmatory study to supplement the existing STRONG data on the intrathecal formulation of AVXS-101 in older patients with spinal muscular atrophy. The company says the agency acknowledged the potential of AVXS-101 IT in
Drugs
A North Carolina federal court decision dismissing all claims raised by Exela Pharma Sciences against Sandoz due to federal preemption is cited by attorney James Beck (Reed Shaw) as a primer for defense lawyers on the ways that preemption precludes private plaintiffs from second-guessing FDA decisions on the marketing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics” (OMB Control Number 0910–0850). The collection supports a guidance under the same title that describes an effort
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