Devices
FDA has cleared a Synedgen 510(k) for its Catasyn Advanced Technology Wound Hydrogel for use under the direction of a health care professional and over-the-counter (OTC) use. When administered by a healthcare professional, Catasyn can be used for dressing and managing partial to full thickness dermal ulcers
FDA Policy/General
Federal Register notice: FDA has announced a 6/26 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to review a Pain Therapeutics NDA for an NDA for oxycodone extended-release capsules, indicated for managing pain severe enough
Drugs
A 9/18-9/22/17 FDA inspection at Nox Bellcow Cosmetics, Guandong Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/9 Warning Letter. Specific violations cited were: * failing to establish an adequate quality control unit with the responsibility
Drugs
An 11/13-11/17/17 FDA inspection at Cerno Pharmaceuticals, Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations and misbranding regulations in the firm’s production of finished pharmaceuticals. A 5/15 Warning Letter says the violations were: * failing to withhold from use each lot
Drugs
FDA has released a seven-item Form 483 following a 5/1 inspection of Biocon’s Bangalore, India drug substance and drug product manufacturing facility. For example, FDA investigators cited the firm for not adequately demonstrating its disinfection efficacy. The firm was also cited for a deficient environmental monitoring effort
FDA Policy/General
FDA has published a guidance on “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application” that describes the agency’s enforcement approach with respect to such during the period before a final sunscreen monograph becomes effective. The document notes that OTC sunscreens marketed without approved applications and containing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry: Controlled Correspondence Related to Generic Drug Development” (OMB Control Number 0910-0797). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has established a public docket to assist with developing a policy or guidance document on assessing pH-dependent drug-drug interactions (DDIs). The agency notes that recent draft guidance documents only focus on enzyme- and transporter-based DDIs and do not include a framework for assessing
Drugs
Avadel Specialty Pharmaceuticals, which markets Noctiva (desmopressin acetate) nasal spray for treating nocturia due to nocturnal polyuria, is asking FDA to impose requirements on NDAs for desmopressin acetate products with that indication, including a resubmitted Ferring NDA for its Nocturna (desmopressin acetate). In its 5/18 petition, Avadel asks that
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Emmett F. Branigan Bellingham, WA (5/7): FDA inspected the physician’s office 1/29-31 and documented significant GMP deviations involving human cells, tissues, and cellular and tissue-
Devices
Abbott has recalled its HeartMate 3 Left Ventricular Assist System due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. “Occlusion of the outflow graft can reduce or stop pump flow and set off a
Devices
In a 5/10 Webinar, CDRH staff updated the digital health software precertification pilot program. Center associate director for digital health Bakul Patel went over the Digital Health Action Plan and the steps in the precertification pilot. He said the Center is currently about one-third of the way into
Drugs
FDA has issued a draft guidance, Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations, with recommendations for conducting in vivo absorption trials for the subject ingredients. The document says a maximal usage trial (MUsT) is a standard
Devices
FDA has cleared a Providence Medical Technology 510(k) for its DTrax Spinal System, indicated for use in posterior cervical fusion in patients with cervical degenerative disc disease. The set of surgical instruments include several specialized single-use devices such as a facet joint access instrument, lateral mass decortication trephine,
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Bioanalytical Method Validation.” The document incorporates public comments to a revised 2013 draft as well as the latest scientific feedback concerning bioanalytical method validation. It is intended to provide the most up-to-date information needed by drug developers to
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.” The document provides recommendations to industry for establishing the clinical effectiveness of such drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has published a list of PMAs that have recently been approved. The list provides the public with the availability of the associated PMA safety and effectiveness summaries. To view the notice, click here.
Drugs
The U.S. House of Representatives has passed S. 204, the Senate version of the Right to Try Act that was passed by that chamber 8/2017. Health advocacy group Public Citizen says that the “Senate’s seriously flawed False Hope legislation, opens the gate to a dangerous, uncharted pathway
Drugs
FDA commissioner Scott Gottlieb says the agency will follow its 11/2017 regenerative medicine advanced therapy designation guidance with a similar framework explaining how FDA will address manufacturing issues and the development pathway for gene therapy products. In a 5/22 presentation to the Alliance for Regenerative Medicine annual board
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the inclusion of a model-informed drug development (MIDD) program in PDUFA 6, but sees areas of MIDD pilot that need additional clarification. The association’s comment letter identifies the areas as the goal, format, eligibility criteria, and selection process.
Drugs
MBI Distributing has recalled all lots of its homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir. The drug products have been found to be manufactured with a lack of adequate controls, according to a recall notice. “Manufacturing products
FDA Policy/General
Federal Register notice: FDA has made available a draft revised guidance for industry entitled “Documenting Electronic Data Files and Statistical Analysis Programs.” The document is intended to inform sponsors about recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine to support new animal