Devices
CDRH officials have provided their viewpoint on differing clinical trial considerations in producing data to justify marketing approval or clearance. Writing in a 6/6 New England Journal of Medicine review article, CDRH director Jeff Shuren and Office of Device Evaluation clinical trials director Owen Faris acknowledge the shift to
Drugs
FDA should refrain from approving a generic copy of United Therapeutic Corp.’s Tyvasco (treprosrinil) if it determines that the proposed generic device and components differ in critical design attributes or if the generic delivery system would require patients to be retrained in use of the device, according to a
Drugs
FDA has released a guidance on “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically. It also implements the electronic submission requirements outlined
Devices
FDA has cleared a Qiagen 510(k) for the ipsogen JAK2 RGQ PCR Kit for detecting mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV), according to the agency. Diagnoses of
FDA Policy/General
Federal Register notice: FDA has announced a 4/13 Antimicrobial Drugs Advisory Committee meeting. Panel members will discuss the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections. Examples of such drugs include those that are only active against Pseudomonas aeruginosa
Drugs
FDA has approved two Gilead Sciences supplemental NDAs for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Previously, the therapies were approved to treat HCV in adults. According to an FDA news release, Harvoni is indicated for treating pediatric
Drugs
GlaxoSmithKline has recalled 593,000 Ventolin HFA (albuterol sulfate) inhalation aerosol, 90 mcg per actuation (200 metered doses) due to a manufacturing defect. The Class 2 recall involves 3 lots — 6ZP9848, 6ZP0003, and 6ZP9944. According to a recall notice, there have been an “elevated number of units with out of
Drugs
FDA has approved a Supernus Pharmaceuticals supplemental NDA for a label expansion for Trokendi XR (topiramate) to include migraine headache prevention in adults and adolescents 12 years and older. “Trokendi XR, with its novel formulation, provides full 24 hour coverage for patients with smooth pharmacokinetics compared to the immediate-release
Drugs
Three researchers who compared drug review and approval times between 2011 and 2015 for FDA and the European Medicines Agency (EMA) say that FDA is consistently faster. Writing in a letter to The New England Journal of Medicine, the researchers conclude that their analysis “provides reassurance that FDA continues to
Devices
The latest annual Emergo study of 510(k) submissions to FDA looked at some 15,000 applications cleared by the agency between 2012 and 2016 and determined that U.S. manufacturers are submitting applications less frequently than in previous years, while submissions from foreign countries have increased. The firm’s
Drugs
When FDA commissioner-nominee Scott Gottlieb is confirmed by the Senate, his “highest immediate priority” will be to assess whether the agency has adequate authorities and resources to address the U.S. opioid crisis. “I think this is a public health emergency on the order of Ebola and Zika, and
Drugs
FDA has cleared a Bausch + Lomb 510(k) for the Stellaris Elite Vision Enhancement System, the company’s next generation phacoemulsification cataract platform. The device features Adaptive Fluidics, which combines “precise aspiration control with predictive infusion management to create a highly responsive and controlled surgical environment for efficient cataract lens
FDA Policy/General
A Wall Street Journal opinion piece has dismissed Democrat lawmakers’ criticisms of FDA commissioner-nominee Scott Gottlieb’s close ties to industry, calling for his quick confirmation. Democrats criticized the nominee’s industry investments and consulting roles during a 4/5 Senate confirmation hearing (see our coverage here), which the
Devices
FDA says that 23andMe can market its Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions. An agency statement says they are the first direct-to-consumer tests authorized by FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which
Drugs
In a move to position drug companies as patient advocates against health insurers, Pharmaceutical Research and Manufacturers of America (PhRMA) has launched a “Share the Savings” campaign to educate the public about the lack of rebate pass-through for commercially insured patients with high deductibles and coinsurance. The association says
Devices
New York attorney general Eric Schneiderman is using state trade laws to extract concessions and monetary penalties from mHealth app developers, according to attorneys Kristi Kung and Sean Cuddihy (Sheppard Mullin). Writing in an online blog post, Kung and Cuddihy say Schneiderman has taken action against Israel-based Matis for
Drugs
Yale School of Medicine cardiologist Harlan Krumholz says that the solution to speeding drug breakthroughs should not be taking shortcuts in evidence generation, but rather leveraging emerging methods and networks that can potentially generate robust clinical evidence faster, cheaper, and better. “In a digital age, we can push for better
Drugs
A Foley online white paper, “Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Device Industries,” is intended to help industry members focus on cybersecurity and intellectual property asset issues in an accessible and practical way. The guidebook says that for life science and medical device companies it is “mission critical
Drugs
Silvergate Pharmaceuticals is asking FDA to impose specific bioequivalence (BE) requirements on any ANDA citing its antihypertensive Epaned (enalapril maleate) oral solution 1 mg/mL as the reference-listed drug. The company asks that any such ANDA not be approved unless it contains sufficient evidence data to establish in vivo
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supported establishment of the FDA Program for Enhanced Review Transparency and Communication under PDUFA 5 and looks forward to working with the agency on it during PDUFA 6. “The PFUDA 6 proposed commitment letter builds upon the success of the program
Drugs
Attorney Sheldon Bradshaw (King & Spalding) says changes are needed to penalties in the Federal Food, Drug, and Cosmetics Act (FFDCA) for drug counterfeiting and diversion of drugs intended for foreign countries into the U.S. Writing in a Washington Legal Foundation Legal Backgrounder, Bradshaw says that the integrity of
Devices
Following reports of a new outbreak of antibiotic-resistant infections associated with duodenoscopes, Sen. Patty Murray (D-WA) is asking Olympus Corp. officials to confirm that its “repaired” closed-channel duodenoscopes are safe for use. Murray says the scopes in question were reportedly rebuilt under an agreement between Olympus and