FDA Policy/General
Menarini-Silicon Biosystems has completed its agreement to purchase all the assets and relevant business related to the CellSearch Circulating Tumor Cell System from Janssen Diagnostics. The FDA-cleared blood test is intended for detecting and enumerating circulating tumor cells (CTCs) to help manage patients with metastatic breast, prostate, and
Drugs
Janssen says it supports policies for biologics and biosimilars that are guided by patient safety and clinical considerations and are consistent with the protection of intellectual property. In a comment on an FDA draft guidance with questions and answers on promotional labeling and advertising considerations for prescription biological reference and
Drugs
FDA has approved Cipla Limited’s generic form of Merck’s Proventil HFA (albuterol sulfate) metered-dose inhaler 90 mcg/inhalation for treating or preventing bronchospasm in patients age four years and older who have reversible obstructive airway disease and for preventing exercise-induced bronchospasm in the same age group.
Drugs
Commenting on a 3/9 FDA/Federal Trade Commission workshop on a competitive marketplace for biosimilars, Pfizer says it welcomes steps FDA has taken to address misinformation about the products. The steps include publishing a draft guidance providing that reference product promotional materials should avoid representing or suggesting that a
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Global Treat Srl, Galati, Romania (3/31): FDA inspected the firm 9/2019 and cited significant GMPs for finished pharmaceuticals. For example, Global Treat failed to perform, for each
FDA Policy/General
Federal Register notice: FDA has corrected a 1/8 Federal Register notice that announced the withdrawal 23 ANDAs. Before FDA withdrew the approval of the ANDAs, Casi Pharmaceuticals informed the agency that it did not want its applications withdrawn. Because Casi timely requested that approval of these ANDAs not be
FDA Policy/General
Federal Register notice: FDA has released a report providing options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs for human drug and biosimilar biologic reviews under the agency’s user fee program. The agency is seeking comments on the report, and after
FDA Policy/General
Federal Register notice: Due to the current Covid-19 health emergency, FDA has postponed a 4/21-planned Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members were scheduled to discuss a GlaxoSmithKline supplemental NDA for Trelegy Ellipta, a fixed-dose combination (fluticasone furoate, umeclidinium, and vilanterol) inhalation for reducing all-
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” (OMB Control Number 0910-0697). The collection allows customer and stakeholder feedback on their perceptions, experiences and expectations. It is intended to provide an early
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice” (OMB Control Number 0910–0543). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has rescheduled for 5/5 a public meeting entitled “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments.” The meeting now will take place by Webcast only. To view the notice, click here.
FDA Policy/General
Absolute Antibody Ltd. and Kerafast Inc. say they have agreed to a merger to improve the selection of research tools available to the scientific community. Absolute Antibody specializes in the sequencing, engineering and recombinant production of antibodies. It says its catalog offers more than 3,400 recombinant antibodies in new
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111” (OMB Control Number 0910-0606). The Dietary Supplement Health and Education Act added section 402(g) on good manufacturing
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Certification of Identity; Form FDA 3975” (OMB Control Number 0910-0832). The form is required when an individual making an Freedom of Information Act (FOIA) request or Privacy Act request for records about the person and he/
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “Special Protocol Assessments.” A guidance under the same title describes procedures for sponsors to request special protocol assessments and for FDA to act on such requests. It provides information on how FDA interprets and applies provisions that
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA from Class 3 (product codes MZP and OBF) to Class 2 (general controls and special controls), subject to premarket
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV from Class 3 (product code MZO) to Class 2 (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation
FDA Policy/General
Federal Register notice: FDA has amended its medical device regulations to reflect changes to CDRH’s organizational structure, including the reorganization of its offices. The revisions replace references to the obsolete offices and positions with the current information, update the physical addresses for such offices, and correct inaccurate citations. To
FDA Policy/General
Federal Register notice: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during the first quarter of this fiscal year. The agency is also making available summaries of the basis of approval and environmental review documents,
FDA Policy/General
The research proposed by CDER’s Office of Prescription Drug Promotion into celebrity endorser status and explicitness of payment in a direct-to-consumer promotion will likely reflect the opinions of a younger, female-skewed population, according to Duke University’s SciReg Lab in a 3/30 comment letter. The
FDA Policy/General
Federal Register notice: FDA is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)) as indicated in lists published on 4/13/2017 and 7/11/2017. The agency says the revisions are necessary to correct editorial errors to ensure that the codified
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The document discusses requirements for manufacturers to provide FDA timely, informative notifications about changes in the production of certain drugs and