Drugs
Public Citizen says that an FDA draft guidance on assessment of drugs’ pressor effects “is vague and will thereby fail to effectively identify the cardiovascular risk of drugs that have hypertensive effects.” The advocacy group’s comment letter lists several limitations of the draft and recommends several revisions. Roche/Genentech
FDA Policy/General
Former FDA commissioner Robert Califf and researchers at Verily Life Sciences, a company developing digital measurement tools, say they believe that data-driven psychiatry is possible and that digital measurement tools and analytics, as “objective yardsticks,” can help bring that future about. Writing online in npj Digital Medicine, the researchers
Drugs
FDA has approved a Shire BLA for Takhzyro (lanadelumab-flyo) injection for preventing hereditary angioedema (HAE) attacks in patients 12 years of age and older. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent swelling attacks in various parts of the body. The company
Drugs
FDA has approved Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) in combination with Genentech’s rituximab for treating Waldenström's macroglobulinemia (WM), a rare blood cancer. Imbruvica first received FDA approval in WM as monotherapy in 1/2015 under the breakthrough therapy designation pathway. This is the ninth FDA approval
Devices
CathWorks has submitted a 510(k) for its CathWorks FFRangio System, a fractional flow reserve (FFR) device that is intended to deliver objective multi-vessel physiologic measurements to optimize and confirm intraprocedural percutaneous coronary intervention therapy decisions. “The FAME trials clearly demonstrated the clinical and economic value of FFR in
Devices
FDA 8/24 sent a Warning Letter to a Zimmer Biomet subsidiary’s manufacturing facility in Warsaw, IN over GMP issues documented in an April inspection. “We have provided written responses to the FDA detailing corrective actions underway to address the FDA’s observations and have provided, and will continue
Biologics
Pfizer has petitioned FDA to issue a guidance document to clarify “appropriate sponsor communications about the nature and properties of biosimilar products.” The petition requests that the guidance permit “truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics, relative to reference product(
Drugs
Pharmaceutical Quality Site Visit Program Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. 08/24/2018 Plasma Lyte Not Withdrawn Due to Safety/Efficacy Federal Register notice: FDA determines that Plasma – Lyte M And Dextrose 5% and
FDA Policy/General
DEVICES FDA has approved Medtronic’s Implantable System for Remodulin for treating patients with pulmonary arterial hypertension (PAH). The device/drug collaboration leverages Medtronic’s SynchroMed II drug delivery system and cardiac catheter technologies to deliver United Therapeutics’ Remodulin (treprostinil) injection. United Therapeutics will lead the product’s promotion with
FDA Policy/General
Federal Register notice: CDER has announced the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. Drug companies are invited to participate by submitting a proposal to OPQ. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Plasma – Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to withdraw ANDA approvals that reference the drug products, and it will allow
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.” The agency says that for patients with hematologic malignancies and oncologic diseases that have standard effective therapy available,
Drugs
The U.S. Court of Appeals for the Seventh Circuit has reversed a lower court decision and $3 million verdict in a product liability case that attempted to hold GlaxoSmithKline (GSK) responsible for injuries caused by a drug, paroxetine, it neither manufactured nor sold. The appeals court decision held that
Drugs
FDA has approved an Ortho Dermatologics NDA for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients nine years of age and older. Altreno is the first formulation of tretinoin in a lotion, according to the company. In clinical trials, the lotion demonstrated proven
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Prescription Drug User Fee Cover Sheet; Form FDA 3397” (OMB Control Number 0910-0297). The cover sheet is designed to provide the minimum necessary information to determine whether a fee is required for review of an application,
Drugs
The Senate 8/23 passed a bipartisan amendment introduced by Sens. Chuck Grassley (R-IA) and Dick Durbin (D-IL) that provides Health and Human Services with $1 million to implement rules requiring pharmaceutical companies to list prices of their prescription drugs in direct-to-consumer advertisements. “The amendment helps
Devices
FDA has granted Dthera Sciences a breakthrough device designation, for its Alzheimer’s treatment, DTHR-ALZ. If approved , the device would become the first non-pharmacological prescription treatment for Alzheimer’s symptoms. It is intended for use in mitigating the symptoms of agitation and depression associated with major neurocognitive disorder
Drugs
An FDA 4/16 public workshop on Evaluating Inclusion and Exclusion Criteria in Clinical Trials addressed the underrepresentation of various populations in clinical trials, how eligibility criteria affect patient access to investigational drugs and enrollment in clinical trials, alternative clinical trial designs that may increase the enrollment of diverse populations,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Sun Protection Factor Labeling and Testing Requirements for Over-the-Counter Sunscreen Drug Products.” The collection is related to a 2011 final rule establishing labeling and effectiveness testing requirements for certain OTC sunscreen products containing specified active
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment.” The document discusses the underlying pathophysiology and structural progression of osteoarthritis and how these should be considered when proposing clinical trial endpoints. To view the
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee. Nominations received by 10/22 will be given first consideration for membership on the panels. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Danocrine (danazol) Capsules, 50mg, 100mg, and 200mg, were not withdrawn from sale for reasons of safety or effectiveness, except for an indication for fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness. The determination means that FDA will not begin