Drugs
Phillips Company is recalling all lots of its Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneed, StaphWash, StringMed, NoPain, and LidoMed topical products to the retail level. In a statement published by FDA, the company says the recall follows an FDA inspection that found significant manufacturing practices calling into question the products’
Drugs
BioMedEcon is asking FDA to require labeling changes for manufacturers of dopamine agonists used to treat restless leg syndrome including risks of serious mental disorder reactions. The petition specifically cites Mirapex (pramipexole), Requip (ropinirole HCl), and Neupro (rotigotine). The agency is asked to: * require addition of a Boxed Warning to
FDA Policy/General
Federal Register notice: FDA has announced a 7/10-11 public workshop entitled “Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities.” The workshop is intended to discuss challenges in using
Drugs
Achelios Therapeutics says it is planning a 505(b)(2) NDA for Topofen (ketoprofen), a topical formulation of the non-steroidal anti-inflammatory drug (NSAID) for treating acute and chronic migraine. The company says it recently completed a Phase 2a study demonstrating that topical application to facial areas innervated by
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Color Additive Certification Requests and Recordkeeping—21 CFR Part 80— OMB Control Number 0910–0216.” The notice involves FDA’s regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics, or medical devices
Drugs
FDA has granted Omeros Corp. a breakthrough therapy designation for OMS721 for treating immunoglobulin A (IgA) nephropathy. The monoclonal antibody is designed to target mannan-binding lectin-associated serine protease-2 (MASP-2), the “effector enzyme of the lectin pathway of the complement system,” according to the company. The designation
Devices
A 10/21-11/4/16 FDA inspection at The See Clear Company, Norcross, GA, found violations of the Quality System Regulation in the firm’s work as a specification developer of soft contact lenses for daily wear under nine different brand names. A just-released 2/14 Warning Letter
Drugs
FDA commissioner Scott Gottlieb says that as part of his initiative to identify more steps his agency can take to address opioid addiction, FDA will hold a 7/10-11 public meeting focusing on the question of whether the agency has the right information to determine whether opioid medications with
Devices
The HHS Cybersecurity Task Force has issued a report with six high-level imperatives, recommendations, and action steps intended to strengthen cybersecurity in the healthcare sector. The task force was created in the Cybersecurity Act of 2015 to address the challenges the healthcare industry faces when securing and protecting itself
Drugs
Based on a data monitoring committee recommendation, Merck has paused new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring Keytruda (pembrolizumab) treatment in combination with other therapies in multiple myeloma. “The pause is to allow for additional information to be collected to better understand more reports of death
Drugs
FDA says it has approved five-year new chemical entity exclusivity for Pfizer’s Duavee (conjugated estrogens; bazefoxifene acetate), rendering moot a company 9/30/16 petition requesting the action in light of a DC federal court decision in Ferring Pharmaceuticals v. Burwell. The agency response says that at the
Drugs
FDA says it has entered into a long-term partnership with CancerLinQ, the American Society of Clinical Oncology’s big data initiative, to use cancer patient information and big data analytics to examine the real-world use of emerging and newly-approved cancer therapies. A statement issued by CancerLinQ says
Drugs
Stakeholders are praising FDA for proposing to create an Office of Patient Affairs (OPA). For example, the Biotechnology Innovation Organization (BIO) says it “applauds the agency for its continued commitment to advancing the science of integrating patient perspectives into drug development and regulatory review processes. We also support FDA’s
Drugs
Bristol-Myers Squibb has recalled one lot (#HN0063) of its blood thinner Eliquis (apixaban) 5 mg tablets after a customer complaint said a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets. “Patients who are prescribed Eliquis 5 mg for an irregular heartbeat (atrial
Devices
FDA has cleared an Etiometry 510(k) for the Inadequate Oxygen Delivery (IDO2) Index for monitoring intensive care unit (ICU) patients aged 12 years or younger. Originally cleared by the agency in 2016 for tracking the clinical risk of inadequate oxygen delivery to neonatal patients, the new clearance now allows
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. A-S Medication Solutions Libertyville, IL (6/5): FDA recently reviewed the firm’s listing files and has identified many instances where the listing information failed to comply with
Drugs
Boehringer Ingelheim says FDA should ensure that any NDA for a fixed-dose, triple-combination, inhaled drug product intended to treat patients with chronic obstructive pulmonary disease is not approved as safe and effective unless it meets Combination Rule requirements. In a petition, the company asks that FDA not approve
Devices
FDA has cleared an I-Bone 510(k) for the iFuse-3D Implant, which the company describes as the first 3D-printed titanium implant for use in the sacroiliac joint. The company says it developed a proprietary 3D-printing technology “to create an implant with a unique patented fenestrated design
Devices
FDA has cleared a Techlab 510(k) for its E. Histolytica Quik Chek, a rapid diagnostic test for detecting pathogenic E. histolytica that does not cross react with non-pathogenic Entamoeba dispar. The test targets an adhesin protein unique to E. histolytica, an intestinal parasite which infects an estimated 50
Drugs
FDA has cleared a GenMark Diagnostics 510(k) for both its ePlex instrument and Respiratory Pathogen Panel. The company describes ePlex as a transformational new in vitro diagnostic platform that integrates nucleic acid extraction, amplification, and detection processes into an automated, sample-to-answer system. The panel detects over 20
Biologics
Biosimilar products are likely to launch faster under a 6/12 U.S. Supreme Court ruling that they do not have to wait until FDA approval to provide a required six-month marketing advance notice. In Sandoz vs. Amgen, the justices ruled that biosimilar applicants may provide notice either before
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection involving new research entitled “Utilization of Adequate Provision among Low to Non-Internet Users.” The primary purpose of the research is to examine the value of including both the 1-800 number and print ad as part of