Drugs
Advocacy group Public Citizen has petitioned FDA to add cesium chloride to its 503A Category 2 list of bulk drug substances identified by the agency as presenting a significant safety risk in drug compounding. The group says FDA has dragged its feet in adding the drug to the listing, noting
Drugs
The FDA Toxicology Working Group has laid out its Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments of FDA-regulated products. FDA acting chief scientist Denise Hinton writes in an FDA Voice online post with Center for Food Safety and Applied
Drugs
FDA has granted full approval for Genentech’s Avastin (bevacizumab) for treating adults with glioblastoma that progressed following prior therapy. Avastin was previously approved under the agency’s accelerated approval program, which requires confirmatory evidence in order for it to be converted to full approval. The approval decision was based
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a 9/8 notice seeking input on existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction. Comments now can be submitted until 2/5/2018. To view the notice, click here.
Drugs
FDA has accepted for review an Insys Therapeutics NDA for what it calls a novel formulation of buprenorphine as a sublingual spray for managing moderate-to-severe acute pain. The agency has set a user fee review target date of 7/28/2018. The submission is based primarily on a
Drugs
The Supreme Court has invited the Solicitor General to submit a brief outlining the views of the United States on Merck’s request that the high court hear its appeal of a 3rd Circuit court decision involving a state law failure-to-warn claim for the company’s Fosamax (alendronate
Devices
A 6/22-7/5 FDA inspection at Hand Biomechanics Lab, Sacramento, CA, found Medical Device Reporting and Quality System Regulation violations in the firm’s manufacturing of bone fixation fastener systems. An 11/16 Warning Letter says specific violations were: * failing to submit a report to FDA no later
Drugs
The Los Angeles Times says that researchers who evaluated four FDA programs designed to speed drug approval found that 105 drugs and biologics approved between 1/2012 and 12/2016 went through the approval process with one of four designations intended to speed the path to approval, while 69 medications
Drugs
Writing in the Journal of the American Medical Association, three researchers say the existing drug patent system is poorly designed to motivate discoveries of new uses for off-patent drugs, and suggest other techniques that could be used. “With the long histories, established safety records, and low prices of generic
Drugs
A 6/16-6/22 FDA inspection at Hangzhou Facecare Cosmetics Co., Hangzhou, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/17 Warning Letter. Specific violations cited in the letter were: * failing to have, for each batch of drug product,
FDA Policy/General
Federal Register notice: FDA has announced the names of the members who will serve on its Performance Review Board. The board is directed to provide fair and impartial review of senior executive service (SES), senior professional and Title 42(f) SES Equivalents performance appraisals, bonus recommendations, and pay adjustments. To
FDA Policy/General
Federal Register notice: FDA is providing notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s BLA: AbbVie, Inc., et al. v. Boehringer Ingelheim Intl. GMBH et al (17-cv-01065 and filed on Delaware
Devices
Simple Diagnostics has recalled three lots of Pharmacist Choice Alcohol Prep Pads, which were manufactured by China-based Foshan Flying Medical Products, due to sterility assurance and other quality issues. Using the suspect Alcohol Prep Pads could result in adverse events such as infections, according to a recall notice. To
Drugs
The Biosimilars Forum is calling on FDA to build appropriate flexibility into a final guidance on statistical approaches to evaluate analytical similarity, taking into account the complexity of the subject matter and its applicability to diverse biosimilar development programs. In its comments on a draft guidance, the group says that
Drugs
South Korean biopharmaceutical company Medytox is petitioning FDA not to approve a Daewoong Pharmaceuticals neurotoxin product that is the subject of an Evolus BLA due to false statements about a botulinum toxin strain and concerns about data integrity and the impact on patient safety. In its petition, Medytox says that
Devices
A plan to end all use of dental amalgam in the European Union (EU) by 2022 was agreed to last week in Berlin, Germany, by representatives of EU governments, dentistry, environmental organizations, health professional associations, and consumer groups from across the continent, according to Washington-based Consumers for Dental Choice
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Technical Considerations for Additive Manufactured Medical Devices” that is intended to provide initial thoughts on technical issues specific to 3-dimensional (3D) printing. The document also covers testing and characterization for final finished devices fabricated using additive manufacturing. To view
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.” The document modifies the agency’s current policy on IDE categorization, which assists CMS in determining whether or not
FDA Policy/General
Attorney Glenn Lammi, chief counsel for Washington Legal Foundation’s (WLF) legal studies division, writes in an online WLF Legal Pulse that FDA is once again appearing in the courts to argue for uniform, national regulation of consumer products. “In the past decade, private litigants and state officials have increasingly
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 Facecare Cosmetics Co. Hangzhou, Zhejiang, China (11/17): FDA inspected the firm in June and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to
Biologics
FDA has approved an Amgen supplemental BLA for Repatha (evolocumab) for preventing heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. Repatha is the first PCSK9 inhibitor to achieve this indication, according to the company. Approval was based on data from a cardiovascular outcomes study (FOURIER) demonstrating
Drugs
FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80 mg/mL for treating adults with active psoriatic arthritis (PsA). The therapy was first approved 3/2016 for treating adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Approval was based on data