Drugs
FDA says that the serious side effects associated with fluoroquinolone antibiotics generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. An agency drug safety communication says that an FDA safety review found that when fluoroquinolones are used systemically, they are
Drugs
Aegerion Pharmaceuticals has reached preliminary agreements with the Department of Justice and the Securities and Exchange Commission involving a settlement of ongoing investigations by the feds into the company’s sales activities and disclosures related to Juxtapid (lomitapide). Under the agreement, the company will pay both agencies over five years
Drugs
FDA has granted AstraZeneca an orphan drug designation for the investigational MEK 1/2 inhibitor, selumetinib, indicated for adjuvant treatment of patients with Stage III or IV differentiated thyroid cancer. The condition is diagnosed in about 60,000 people in the U.S. each year, the company says. Some patients
Devices
FDA has cleared an EndoGastric Solutions 510(k) for the EsophyX Z device for treating gastroesophageal reflux disease using transoral incisionless fundoplication. “Designed for compatibility with the company’s existing 7.5 mm SerosaFuse Implantable Fastener cartridges, the device allows physicians to reconstruct the gastroesophageal valve and then secure tissue
Drugs
Rep. Mia Love (R-UT) has introduced the Over-the-Counter Contraceptives Act of 2016 (H.R. 5138) to “allow women greater access to safe and effective contraceptives.” Under the measure, FDA would be required to give priority review to any supplemental application for a contraceptive drug that (1) involves
Drugs
A Harvard School of Public Health poll finds that a majority of Americans don’t favor some key provisions of the 21st Century Cures Act and its companion Senate legislation. The poll also found that few people think FDA does a good job of regulating prescription drugs and medical devices.
Drugs
A citizen petition filed by Hyman, Phelps & McNamara on behalf of an unnamed client asks FDA for immediate enforcement action against unapproved potassium chloride oral solution drug products being marketed by Pharmaceutical Associates. The petition says the drugs are being marketed in violation of the Federal Food, Drug, and
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the information collection provisions of abbreviated new animal drug applications (ANADAs). The information required to be submitted as part of an ANADA is described in FDCA 512(n)(1). Among other things, an ANADA is required to contain information to show
FDA Policy/General
Federal Register Notice: FDA will hold a public meeting 6/10 to gather stakeholder input on the potential development of a user-fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user-fee program would provide funding to supplement congressional non-user-fee appropriations, and would support
FDA Policy/General
Federal Register Final rule: FDA is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to the agency. This report would include the amount of each such ingredient in the
Drugs
The Personal Care Products Council says that while it supports the FDA intent to harmonize requirements for prescription and OTC products and make them consistent with long-standing agency policy, it has some concerns about the agency’s proposed rule on fixed-combination and co-packaged drugs covering applications for
Drugs
A petition from two Yale University School of Medicine professors of endocrinology and metabolism asks FDA to reconsider labeling changes relating to the Contraindications and Precautions sections of labeling for metformin. The petition asks that the Precautions section specifically recommend use of a lower dose of the drug (up to
Drugs
CDER director Janet Woodcock says there is a knowledge chasm in translational science that CDER is helping to fill. Speaking on a Director’s Corner podcast, she says that every disease should have its own translational program and natural history studies that look at disease progression over time. (Woodcock defines
Devices
NDA Partners has formally added medical device expert consulting to its service offerings for product development and regulation. The device team offers a “wide range of services to assist in all phases of the regulatory processes involved with medical devices and diagnostics, including medical equipment, implants, in vitro and imaging
Biologics
In a letter to FDA this week, a 70-group coalition of healthcare stakeholders, including patient and provider organizations, has urged the use of distinguishable, meaningful suffixes for biosimilars. The letter follows FDA’s departure from “a meaningful to random identifier in the agency’s approval of the second biosimilar,
Drugs
FDA has accepted from H3 Biomedicine an IND application to begin Phase 1 clinical trials for its lead oncology drug candidate H3B-8800. The oral and selective small molecule modulator of splicing factor 3b subunit 1 is being developed as an anticancer therapeutic agent for treating select hematologic malignancies. “Mutations
Drugs
Allergan andGedeon Richter have announced positive results from Venus I, one of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. The study included 157 patients, with 101 randomized to ulipristal acetate 5 and 10 mg and 56 to placebo.
Devices
FDA has granted Lungpacer Medical an Expedited Access Pathway (EAP) designation for the Lungpacer Diaphragm Pacing System for treating patients who have been unable to wean from mechanical ventilation. Traditional mechanical ventilation can be harmful to a patient because it interrupts the normal activation of the diaphragm muscle, which then
Drugs
Sen. Ron Johnson (R-WI) has introduced legislation to prevent the federal government from interfering with implementation of state “Right to Try” laws that allow terminally ill patients, under a doctor’s direction, to access treatments that are being safely used in clinical trials but may be years away from
Drugs
Heritage Pharmaceuticals says it has become aware of the existence of a counterfeit drug product labeled as BiCNU (carmustine for injection) 100 mg, that is being sold and distributed outside of the U.S. BiCNU is primarily used for chemotherapy to treat several types of brain cancer, multiple myeloma, and
Devices
FDA has approved an Integra LifeSciences PMA for its Omnigraft Dermal Regeneration Matrix, indicated for use in treating partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.
Drugs
FDA says it will hold a 6/10 public meeting to hear stakeholder input on the potential development of a user-fee program for nonprescription over-the-counter monograph drugs. A Federal Register notice says that such a program would provide funding to supplement congressional non-user-fee appropriations, and