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 In its comments on a draft guidance, the group says that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
FDA Policy/General
Federal Register notice: FDA has announced six modifications the agency is making to its FDA-Recognized Consensus Standards listing for use in premarket reviews. The listing is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Seven entries have been
Devices
FDA has issued a new guidance on “Technical Considerations for Additive Manufactured Medical Devices 3D Printing of Medical Devices.” The “leap-frog” guidance is intended to bridge today’s innovations with expected innovations coming down the road. FDA commissioner Scott Gottlieb says the new guidance helps the agency prepare for
FDA Policy/General
Federal Register notice: FDA has proposed to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device (product code MBU), into Class 2 (special controls) subject to 510(k) clearance. FDA is also identifying the proposed special controls that it believes are
Devices
FDA has issued a guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions,” which modifies the categorization of IDE devices used in clinical studies. Under the guidance, devices with an approved IDE fall into one of
FDA Policy/General
Federal Register notice: CDER has announced its intent to accept proposals from pharmaceutical companies interested in participating in the Office of Pharmaceutical Quality’s Staff Experiential Learning Site Visit Program. Firms can submit a site visit proposal in electronic or written form by 2/2/2018. To view the notice,
Devices
FDA commissioner Scott Gottlieb has agreed to meet with Rep. Rosa DeLauro (D-CT) and other members of Congress to discuss the safety of Bayer’s controversial contraceptive implant Essure (see earlier story). DeLauro says the meeting was granted on the condition that women who have been affected by Essure
FDA Policy/General
Panel to Review Ciprofloxacin Dispersion for Inhalation NDA Federal Register notice: FDA announces a 1/11/2018 Antimicrobial Drugs Advisory Committee meeting. to review an NDA for ciprofloxacin dispersion for inhalation. 12/01/2017 Meticorten Not Withdrawn Due to Safety/Effectiveness: FDA Federal Register notice: FDA determines that Schering’s
Devices
FDA has approved Foundation Medicine’s FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. An agency news release says that compared to other companion diagnostics previously