FDA Policy/General
Federal Register notice: FDA has developed a list of drug products and categories of drug products that are difficult to compound. The agency has also established a new public docket so that interested parties can nominate other drug products or product categories that were not previously nominated for inclusion on
FDA Policy/General
Federal Register notice: CDRH has announced a Software Precertification Pilot Program to evaluate a new approach for software products, including a precertification program for assessing companies that perform high-quality software design and testing. The voluntary pilot is part of FDA’s ongoing efforts to develop optimal approaches to balance
Drugs
FDA has announced a 9/13 public workshop on “Developing a Framework for Regulatory Use of Real-World Evidence.” Convened by the Duke Center for Health Policy under a cooperative agreement with FDA, stakeholders at the meeting will be asked to discuss the use of real-world data and real-
Drugs
FDA has issued a safety alert after it received recent adverse event reports about Guardian Pharmacy Services’ compounded triamicinolone and moxifloxacin product for intravitreal injection. An agency notice says that the reports were received after at least 43 patients were administered intravitreal (eye) injections at the end of a cataract
Drugs
Advanced Accelerator Applications has resubmitted an NDA for Lutathera (lutetium Lu 177 dotatate) for treating unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors in adults. The re-filing follows a 12/2016 complete response letter that cited issues with the format, traceability, uniformity,
Drugs
A Tennessee federal judge has entered a consent decree of permanent injunction against Crown Laboratories and its CEO to stop the distribution of unapproved and misbranded drugs. The Justice Department says the products include urea creams and lotions intended to treat a variety of skin ailments. In a complaint sought
Drugs
AstraZeneca and Merck say they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza (olaparib) for multiple cancer types. A joint announcement says that Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase inhibitor currently approved for BRCA-mutated ovarian
Drugs
Aradigm has submitted an NDA for Linhaliq (liposomal ciprofloxacin for inhalation) for treating non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. The submission is based on data from the Phase 3 pivotal clinical trial ARD-3150-1202 (ORBIT-4) and confirmatory evidence from the Phase 3
Drugs
Federal Register notice: FDA has classified the assayed quality control material for clinical microbiology assays into Class 2 (special controls). The classification decision is based on a 2015 request from Bio-Rad Laboratories for classification of the Amplichek II device. To view this notice, click here.
FDA Policy/General
Federal Register notice: FDA has classified the balloon aortic valvuloplasty catheter into Class 2 (special controls). The classification decision is based on a 2008 request from NuMED for classification of the NuCLEUS–X Percutaneous Transluminal Valvuloplasty Catheter. To view the notice, click here.
Drugs
Hi-Tech Pharmaceuticals is asking the 11th Circuit Court of Appeals to reverse a lower court decision that DMAA (1,3-dimethylamylamine) does not qualify as a dietary ingredient. “Hi-Tech believes that the court’s failure to find that DMAA is a constituent of a botanical, which would have
Devices
FDA has approved a Quantel Medical PMA for the Easyret fully integrated 577nm yellow photocoagulator, indicated for use to treat certain forms of macular edema and peripheral retinal pathologies. The device is based on Quantel’s proprietary ELBA fiber laser technology, which “delivers pure 577nm yellow wavelength in a uniform
Drugs
Reacting to significant adverse votes from members of two FDA advisory panels against its Rexista abuse-deterrent oxycodone formulation, executives of Canada’s Intellipharmaceutics say they will try to remedy the concerns raised by the panel members by completing human abuse potential studies in relation to the intranasal and oral
Devices
FDA commissioner Scott Gottlieb says the agency is launching a Pre-Cert for Software pilot program that embraces the principle that digital health technologies can have significant benefits to patients’ lives and to the healthcare system by facilitating prevention, treatment, and diagnosis, and by helping consumers manage chronic conditions outside
Drugs
Federal Register notice: FDA has announced a new organizational structure for the Office of the Medical Products and Tobacco to establish the Oncology Center of Excellence (OCE) that is intended to optimize an integrated cross-Center regulatory approach and enhance the coordination of medical product development in oncology. The OCE
Drugs
FDA medical reviewers say that Dynavax’ hepatitis B vaccine Heplisav-B (hepatitis B vaccine recombinant and 1018 ISS adjuvant) is effective, but still has potential safety issues. The reviewers’ assessment is in a briefing document released in advance of a 7/28 Vaccines and Related Biological Products Advisory Committee meeting
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency will postpone sending reduction-in-force (RIF) notices to staff who are funded by user fees until 9/30 unless the FDA Reauthorization Act (FDARA) is signed by President Trump. Previously, FDA officials told Congress that the RIF notices would be mailed at
Drugs
Hyman, Phelps & McNamara says that labeling for Synergy Pharmaceuticals’ Trulance (plecanatide), approved 1/19 to treat chronic idiopathis constipation in adults, fails to contain sufficient side effect information regarding diarrhea. In a citizen petition to FDA, the Washington-based law firm asks that Synergy be required to add additional
FDA Policy/General
Federal Register notice: FDA has announced the availability of a guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” The document notes that FDA does not intend to object to an IRB waiving or altering informed consent requirements
Drugs
The Justice Department says that Jason May, the pharmacist in charge of a Hattiesburg, MS, compounding pharmacy, has pleaded guilty to healthcare fraud charges for his role in a scheme that defrauded TRICARE and private insurance companies out of at least $192 million in payments for medically unnecessary compounded medications.
Drugs
FDA has approved a new Boxed Warning on canagliflozin (Janssen’s Type 2 diabetes drugs Invokana, Invokamet, and Invokamet XR) based on recent safety data (see earlier story) that indicate it causes an increased risk of leg and foot amputations. A recent drug safety communication recommends that patients taking the
Drugs
Mylan says that a Mayne Pharma petition asking the agency to refuse to receive and not approve any ANDA referencing its Doryx MPC (doxycycline hyclate delayed-release tablets) unless specific in vitro dissolution criteria are met “appears to be nothing more than a veiled attempt to delay generic competition by