Drugs
FDA has approved Sunovion’s Kynmobi (apomorphine hydrochloride) to treat the so-called “off-time” when Parkinson’s disease symptoms are not well controlled with oral medication. The Michael J. Fox Foundation for Parkinson’s Research says this is the second agency approval of a drug the foundation helped to
Drugs
FDA has approved a Takeda Pharmaceutical Company NDA for Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands Alunbrig’s current indication to include the first-line setting. The potent and
FDA Policy/General
Federal Register notice: FDA has made available guidance documents related to the C vid-19 public health emergency. The guidances have been implemented without prior comment, but they remain subject to comment under the agency’s good guidance practices. To view the notice, click here.
Drugs
FDA has approved a Chiesi Global Rare Diseases NDA for Ferriprox (deferiprone) twice-a-day tablets for treating patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. The company says the new formulation of twice-a-day Ferriprox 1,000 mg oral tablets eliminates
Devices
A 5/11 CDRH Webinar reviewed the provisions in a 5/6 immediately-in-effect guidance requiring manufacturers of certain medical devices to notify FDA of an interruption or permanent discontinuation in the manufacturing of the specified medical devices during a public health emergency. CDRH Division of All Hazards Response,
Biologics
The CBER Office of Compliance and Biologics Quality says ValeoMD, Millburn, NJ, is using a Web site to market “stem cell therapy” derived from adipose tissue to treat many neurological, inflammatory, and degenerative diseases. A just-released 4/28 Notice of Violation says the firm’s adipose-derived cellular product
Drugs
FDA has issued a request for information (RFI) seeking a potential contractor with expertise in pattern recognition, statistical process control and other emerging concepts to simplify regulatory oversight functions within the CDER Office of Business Informatics. An online GovConWire report says interested parties must have the capacity to provide analyses
Drugs
CalciMedica says it is transitioning an ongoing randomized open-label study to a blinded placebo-controlled trial for Auxora (formerly called CM4620-IE) in patients with Covid-19 pneumonia. The move was recommended by FDA after reviewing a submission of a recent interim analysis of Auxora in patients suffering from
Drugs
Following a 5/19 closed-door lunch for President Trump and Republican senators, Sen. Chuck Grassley (R-IA) said Trump indicated he still wants congressional action on legislation to lower drug prices despite the Covid-19 public health emergency. As reported online by The Hill, Grassley asked Trump if he
Drugs
FDA says agency researchers have been improving (quantitative) structure-activity relationship (Q)SAR models that are used to help predict the mutagenicity of drug impurities and drug substances. An online Regulatory Science Impact Story post says that as a result of the improvements, there is increasing interest from drug developers
Devices
FDA has issued an immediately-in-effect guidance, Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the
Devices
FDA has publicly posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the guidance on Covid-19 tests during the public health emergency. An agency statement (with links to removal list and applicable guidance) says that antibody tests on the
Drugs
The FDA Sentinel operations center at the Harvard Pilgrim Health Care Institute is working with TriNetX, a health research network that generates real-world evidence, to monitor priority drugs used for the care of hospitalized Covid-19 patients. A TriNetX statement says Harvard Pilgrim is leveraging TriNetX’s de-identified
Drugs
Biota Biosciences has recalled five lots of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables because they were marketed without FDA approval. The products are also considered misbranded because their labeling fails to bear adequate directions for use, a recall notice says. “Unapproved new drugs injected into the bloodstream
Drugs
The Stericycle Q1 2020 recall report projects a significant surge in FDA drug and medical device enforcement activity once the Covid-19 public health emergency dies down. The report says there is a good chance there will be a downturn in medical device recall activity in at least the second
Drugs
The Consumer Healthcare Products Association (CHPA) says an FDA draft guidance on flow restrictors for oral liquid drug products “reflects recommendations by the agency for which CHPA members are supportive for the most part.” The association’s comment letter includes input on the Directions for Use section of the guidance
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/5/2022. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by OMB. They are: * National Panel of Tobacco Consumer Studies * Study of Oncology Indications in Direct-to-Consumer Television Advertising * Premarket Approval of Medical Devices * Hazard Analysis and Critical Control Point Procedures for the Safe
Drugs
FDA has approved AztraZeneca and Merck’s Lynparza (olaparib) for treating adults with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide (Astellas and Pfizer’s Xtandi) or abiraterone (Janssen’s Zytiga). The companies
Drugs
FDA has conditionally accepted the proprietary brand name Gimoti for Evoke Pharma’s nasal spray product candidate to relieve symptoms in adult women with acute and recurrent diabetic gastroparesis as resubmitted in Evoke’s 505(b)(2) NDA. The company says the development of the name included research with physicians
Drugs
FDA has issued a guidance, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic, with recommendations for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. The document says the agency anticipates that during the current pandemic industry and FDA workforces may be
Biologics
FDA has issued a guidance, Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma, to recognize the May 2020 version 2.1 standard full-length and abbreviated donor history questionnaires and accompanying materials prepared by the Plasma Protein