Drugs
A 4/13 letter from five House Republicans is questioning FDA commissioner Robert Califf on agency safeguards in place when questionable foreign-made generic drugs are allowed to enter the country to prevent drug shortages. At issue is FDA’s decision to allow Glenmark Pharmaceuticals to import atovaquone from a
Drugs
FDA has issued Alvotech a complete response letter on its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVie’s Humira (adalimumab). The letter cites manufacturing deficiencies that were documented during a 3/17 reinspection of the company’s Reykjavik, Iceland facility. An earlier complete response letter was issued
Drugs
Solgenix says FDA is requiring an additional study to resolve a refuse-to-file letter it received in February for its HyBryte (synthetic hypericin) NDA for treating early stage cutaneous T-cell lymphoma. At a just-completed Type A meeting the agency revealed that it is requiring positive results from
Devices
FDA has cleared a Moximed 510(k) for its MISHA Knee System, an implantable shock absorber for use in patients with medial knee osteoarthritis (OA). The device is indicated for those who failed to find relief from non-surgical or surgical treatment, and are ineligible for, or unwilling to undergo,
Drugs
FDA has released a 13-page Form FDA-483 addressed to Lupin LTD. that cites significant GMP deficiencies from a 03/21-29 inspection of the firm’s Pithampur, India manufacturing facility. According to the inspection document, the company’s investigations of a batch failure did not extend to other
Drugs
The Justice Department says it will seek “emergency relief” from the U.S. Supreme Court after the Fifth Circuit Court of Appeals ruled late 4/12 that while the abortion drug mifepristone can remain on the market it cannot be mailed and thus limits access for women. “The Justice Department
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Over-the-Counter Monograph Order Requests (OMORs): Format and Content.” The document provides recommendations on the information that a requestor should provide in an OMOR and identifies relevant guidance documents to assist requestors in preparing their submissions. To view
FDA Policy/General
Federal Register notice: FDA is announcing a request for information and comments on the development of an FDA data and technology strategic plan. Under the user fee program commitments, FDA is required to develop and publish by 9/30 its strategic plan, which is intended to define and shape the
Drugs
A 4/14 joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee will consider a sNDA from Otsuka Pharmaceutical and Lundbeck for their Rexulti (brexpriprazole) to treat agitation in patients with Alzheimer’s dementia. An FDA briefing paper distributed in
Drugs
The Texas House has approved legislation to create a program that would allow certain drugs to be imported from Canada. The bill must still be debated and voted on by the state Senate. CBS News reports the legislation would require the state to work with Canadian suppliers to select drugs
Devices
FDA has published a final guidance, Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters—Premarket Notification (510(k)) Submissions, with recommendations, including bench testing and coating characterizations for 510(k) submissions for PTA balloon and specialty catheters. The document provides anatomy-specific testing recommendations and expands on the agency’s
Drugs
Responding to a government amicus brief supporting the generic drug industry and asking the Supreme Court to hear an appeal of the so-called “skinny label” case brought by GlaxoSmithKline against Teva over labeling for a generic form of GSK’s heart drug Coreg (carvedilol), GSK says the government doesn’
FDA Policy/General
Federal Register notice: FDA has issued a final order to exempt certain categories of biological products from annual reporting requirements under the Federal Food, Drug, and Cosmetic Act as amended by the Coronavirus Aid, Relief, and Economic Security Act. Biologic makers are required to report to FDA the amount of
Devices
FDA has accepted for review a AlgoDx de novo marketing request for Navoy Sepsis, a clinical decision support software intended to assist healthcare providers at intensive care units (ICU) with predicting sepsis in adult patients. The prediction algorithm software is based on machine learning that “accurately predicts the risk of
Devices
FDA issued a 4/13 updated medical device safety communication to provide transparency for consumers who are awaiting a Philips replacement BiPAP or CPAP machine to clarify that the number of replacement and remediated devices that have been shipped to consumers in the U.S. is considerably less than the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “A Risk- Based Approach to Monitoring of Clinical Investigations — Questions and Answers.” The document provides risk-based approaches for monitoring drug, biologic and medical device investigational studies. It also contains recommendations on planning a monitoring approach, developing the content
FDA Policy/General
Federal Register notice: CDRH has announced its Radiation Sterilization Master File Pilot Program, a voluntary program intended to allow companies that terminally sterilize single-use medical devices using gamma radiation or ethylene oxide to submit Master Files when making certain changes to sterilization sites, methods, or processes under the specific
Drugs
FDA has published a draft guidance, Over-the-Counter Monograph Order Requests (OMORs): Format and Content, to assist requestors in preparing OMORs for submission to the agency. The document provides FDA’s recommendations on the format and content of the information that requestors should provide in an OMOR and identifies
FDA Policy/General
Federal Register notice: FDA has announced a 6/8 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” It will provide an update on topics related to the financial management of the drug, biosimilar, and
Drugs
FDA has published a draft guidance, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, with recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical drug delivery system (TDS). The document says its recommendations relate to studies submitted in support of
Drugs
The National Cancer Institute (NCI) says it has helped to launch a Phase 3 trial of a two-drug combination to treat patients with advanced non-small cell lung cancer (NCSLC). An NCI announcement says the Pragmatica-Lung Study is part of a broader effort by FDA and the National
Drugs
A 10/18-11/17/22 FDA inspection at the Omega Packaging Corp. drug manufacturing facility in Totowa, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/20 Warning Letter says specific violations were: * failing to test samples of each component for identity