Drugs
Addressing healthcare payors at the America’s Health Insurance Plans National Health Policy Conference, FDA commissioner Scott Gottlieb said payors are going to have to decide whether they want to continue to receive the short-term profit that comes with drug rebate programs or are willing to support a system
Drugs
A Tufts Center for the Study of Drug Development survey says that the clinical trial study initiation process remains highly inefficient with wide variation among companies, despite implementation of new technology solutions and practices. “The findings indicate that the site initiation process has become increasingly challenging for sponsors and contract
Drugs
Esperion has reported positive top-line results from a pivotal Phase 3 study (Study 4 or 1002-048) involving its investigational bempedoic acid 180 mg. The trial was designed to evaluate the LDL-C lowering efficacy and safety and tolerability of bempedoic acid versus placebo in patients with, or at
Devices
FDA has cleared a Stryker’s Spine division 510(k) for its Tritanium TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion device intended for use as an aid in lumbar fixation. The hollow implant has a “unique configuration of both solid and porous structures, which are simultaneously built
FDA Policy/General
Yale University researchers say their review of 97 unique direct-to-consumer (DTC) drug ads for 60 unique drugs found that few of the ads complied with FDA regulations. “The overall quality of information presented in ads was low, and suggestions of off-label promotions were common for diabetes medications,
Drugs
FDA has cleared a Panther Orthopedics 510(k) for the Puma System, an implantable flexible fixation device indicated for syndesmosis fixation, hallux valgus reconstruction, and tarsometatarsal fixation. The device was designed to solve problems experienced with stiff metal screws, which serve as stress risers and prohibit normal physiological joint motion,
Devices
FDA says it received 11, 854 medical device reports related to Bayer’s Essure contraception device in 2017, more than double the 5,019 reports received in 2016. “The nature and severity of the reports remain consistent with prior years,” an FDA Essure activity update says. “However, in 2017, 78%
Devices
The 3rd Circuit Court of Appeals has issued the first appellate decision that preemption for multi-component medical devices should be addressed on a component-by-component basis. Attorney Michelle Yeary (Dechert) says the ruling came in an appeal from a Pennsylvania federal court decision in a case involving a
Drugs
FDA has approved an Orthofix International PMA for its next-generation Physio Stim bone growth stimulator. The device provides a non-surgical treatment option for patients who have a nonunion fracture to an extremity that has shown no visible signs of healing. It uses a pulsed electromagnetic field signal to
Drugs
The Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) says it welcomes issuance of an FDA draft guidance to assist ANDA applicants by highlighting common, recurring deficiencies in ANDAs and to provide recommendations on how to avoid these and other similar deficiencies with the goal of minimizing the number
Drugs
Sagent Pharmaceuticals has recalled 10 lots of methylprednisolone sodium succinate for injection (40mg, 125mg and 1g) due to the discovery of high out-of-specification impurity results detected during routine quality testing of stability samples for two lots. The impurity has not yet been identified. An elevated impurity has the
Drugs
FDA has approved a TaiMed Biologics BLA for Trogarzo (ibalizumab-uiyk), a new type of antiretroviral for adult patients living with HIV who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV). The therapy is
Drugs
A 9/25-9/29/17 FDA inspection at Nan San Pharmaceutical Factory, Hong Kong, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, along with other violations, according to a 2/23 Warning Letter. Specific violations cited in the letter were: * failing to perform for
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Nan San (HK) Pharmaceutical Factory Ltd., Hong Kong (2/23): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed
Devices
FDA has expanded the approval of St. Jude Medical’s Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff to include a 15-mm valve size that is small enough to be used in newborn pediatric patients to treat heart defects. The rotatable, two-leaflet valve is designed for
Drugs
Sen. Tina Smith (D-MN) has introduced the Expanding Access to Low Cost Generic Drugs Act to give FDA authority to act as a federal watchdog over so-called “pay-for-delay” agreements in which an innovator drug company pays a generic drug company to delay entry of its generic
Drugs
The CBER Advertising and Promotional Labeling Branch (APLB) says that a Web site, patient brochure, exhibit panel, and sales aid for CSL Behring’s Idelvion (coagulation Factor IX [recombinant] albumin fusion protein) make misleading claims about the product’s effectiveness, causing the drug to be misbranded. A 2/27 Notice
Drugs
An 8/14-8/18/17 FDA inspection at Zhejiang Ludao Technology Co., Taizhou, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/23 Warning Letter. Specific violations cited in the letter were: * failing to ensure that laboratory records included complete
Drugs
FDA released 3/6 the FDA-483 issued following a 2/12-2/20 agency inspection at Aurobindo Pharma, Telagana, India. The nine inspection observations on the form are: * · aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions; * · equipment and utensils are
Drugs
FDA released 3/7 the FDA-483 issued following a 2/12-2/23 inspection at Sun Pharmaceutical Industries, Gujarat, India. Specific observations shown on the form were: * separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products; * · written
Drugs
FDA has approved a TaiMed Biologics BLA for Trogarzo (ibalizumab-uiyk), a new type of antiretroviral for adult patients living with HIV who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV). The therapy is
Devices
FDA has granted 23andMe a de novo marketing authorization for its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (selected variants) — the first direct-to-consumer test to report on three specific breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent.