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
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(
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Register notice: FDA has determined that Plasma – Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for reasons of safety or effectiveness.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Federal Register notice: FDA has made available a draft guidance entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug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,
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
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
FDA Policy/General
Federal Register notice: FDA has announced a 10/19 public meeting entitled “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC).” The meeting is intended to provide stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission
FDA Policy/General
Federal Register notice: FDA has determined that Ditropan XL (oxybutynin chloride) extended release tablets 15mg were not withdrawn from sale for safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. To view the
FDA Policy/General
Federal Register notice: FDA has announced a 9/20 public meeting entitled “Expanding Access to Effective Treatment for Opioid Use Disorder: Provider Perspectives on Reducing Barriers to Evidence-Based Care.” The meeting is intended to generate a discussion with providers and health system stakeholders on medications to treat opioid use
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.” The document is intended to assist sponsors of such drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Quality Attribute Considerations for Chewable Tablets.” The document outlines current thinking on the critical quality attributes that should be assessed during the development of such products. To view the notice, click here.
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 Karic Commodities Hangzhou, China (7/31): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level” (OMB Control Number 0910–0430). The information collection involves the process for formally resolving scientific and procedural disputes in FDA’s CDER and CBER that
FDA Policy/General
Federal Register notice: FDA has announced a 9/20 Pediatric Advisory Committee to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended the comment period for a previous notice about study designs intended to generate data to support substantial evidence of effectiveness for investigational new animal drugs intended for preventing heartworm disease in dogs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Samples and Protocols” (OMB Control Number 0910–0206). The collection supports FDA’s authority to require manufacturers of licensed biological products to submit to FDA samples of any lot along with the protocols showing the results of