Devices
FDA has issued a white paper and will hold a 12/10-11 public workshop to gather feedback and comments on the distinction between servicing and remanufacturing of medical devices. The white paper is intended to guide discussion at the workshop through the agency’s initial thoughts about guiding principles,
Devices
FDA has cleared a Rocky Mountain Orthodontics 510(k) for Orthocaps, a transparent and removable appliance for correcting tooth malpositions. Orthocaps features two different “aligners” for both day and night use, according to the company. The devices are manufactured by Ortho Caps GmbH (Hamm, Germany). During each treatment phase, patients
Drugs
Pfizer and Lilly say a Phase 3 study of the efficacy and safety of subcutaneous administration of their investigational humanized monoclonal antibody tanezumab in patients with osteoarthritis pain met all three co-primary efficacy endpoints. The companies say that in patients with moderate-to-severe osteoarthritis pain of the knee
Drugs
FDA has approved Genentech’s Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and older. The first-in-class drug works by inhibiting polymerase acidic endonuclease, an enzyme essential for viral replication, the company says. “Xofluza has demonstrated efficacy against a wide range of
FDA Policy/General
Federal Register notice: FDA has announced a 12/17 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. The committees will be asked to provide input and advice on strategies to increase the availability of naloxone products intended for use in communities.
Drugs
A new study has concluded that the FDA Amendments Act (FDAAA) of 2007 has led to more clinical trials being registered and resulted reported on ClinicalTrials.gov. The study, published in Trials Journal, examined trials that supported FDA approval of new drugs for neuropsychiatric indications, found that “reporting results on
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Imclone’s Lartruvo, indicated for combination use with doxorubicin for treating adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable
Drugs
FDA has issued a draft guidance, Testicular Toxicity: Evaluation During Drug Development, to assist sponsors who are developing drug products that may have potential adverse effects on the testes, referred to by FDA as testicular toxicity, based on findings in non-clinical studies. The document discusses: * non-clinical findings that
FDA Policy/General
FDA deputy commissioner for policy, planning, legislation, and analysis Anna Abram reviewed 20 years of FDA history in a 10/24 speech to the JAX Healthcare Forum “to illustrate how innovation is truly part of FDA’s DNA. FDA plays an important role in the biomedical ecosystem, working with scientists,
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Genentech’s Tecentriq (atezolizumab), indicated for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its guidance on “Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products.” The guidance describes procedures for requesting, scheduling, conducting, and documenting such formal meetings. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Wyeth’s Besponsa (inotuzumab ozogamicin), indicated for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The regulatory review period was determined to be 5,298 days, which included 5,057
Drugs
A 6/13-6/29/17 FDA inspection at Auro Pharmacies, a La Habra, CA, outsourcing facility, found that the drug products produced there failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to qualify
Drugs
The FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet 12/17-18 to consider various options for increasing access to naloxone. FDA commissioner Scott Gottlieb says the advisors “will help us weigh logistical, economic, and harm reduction aspects of different strategies. And
Drugs
FDA has released the FDA-483 issued following a 9/24-9/28 inspection at Cipla Limited, a Goa, India, drug manufacturer. The two inspection observations were: * batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing;
Drugs
Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee will meet 10/24-25 to discuss the agency’s 2008 guidance “Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” An agency briefing document distributed in advance of the session says that concerns were
Drugs
Several companies have responded to an FDA request for comment on issues surrounding orphan drug exclusivity for Eagle Pharmaceuticals’ Bendeka (bendamustine hydrochloride) in light of a federal court order reversing an FDA decision that Bendeka was not entitled to orphan drug exclusivity because it was not clinically superior to existing
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Kirin-Amgen’s Siliq (brodalumab), indicated for treating moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Radius Health’s Tymlos (abaloparatide), indicated for treating postmenopausal women with osteoporosis at high risk for fracture. The regulatory review period was determined to be 4,130 days, which includes 3,735 days that
Drugs
A Tennessee federal judge has entered a consent decree sought by FDA against Keystone Laboratories, Memphis, TN, and its owner and president, barring them from selling over-the-counter drug products until the firm complies with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the decree.
Drugs
Working with international regulatory and law enforcement agencies in Operation Pangea XI, the 11th annual International Internet Week of Action, FDA says it targeted 465 Web sites that illegally sell potentially dangerous, unapproved versions of opioid, oncology, and antiviral prescription drugs to U.S. consumers. An agency statement says the
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Auro Pharmacies La Habra, CA (9/24): FDA inspected the outsourcing facility in June and cited it over serious deficiencies in its