Devices
FDA has released the FDA-483 issued following a 7/17-8/18/17 inspection at Philips Medical Systems, Cleveland, OH. The eight inspection observations listed were: * failing to review, evaluate, and investigate where necessary complaints involving the possible failure of a device to meet any of its specifications; * failing
Drugs
Washington Legal Foundation (WLF) says the 1st Circuit Court of Appeals should grant a Warner Chilcott motion asking it to reverse a Massachusetts federal court decision granting standing to plaintiffs in antitrust litigation involving the company’s drugs indicated to treat ulcerative colitis. The WLF amicus brief says it is
Drugs
FDA has approved an Otonomy NDA for Otiprio (ciprofloxacin otic suspension) 6% for treating acute otitis externa (swimmer’s ear) caused by Pseudomonas aeruginosa and Staphylococcus aureus in patients aged six months and older. Otiprio is the first single-dose antibacterial approved by the agency for treating the infection. Topical
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.” It is intended to describe the agency’s interpretation of terms used in the definitions of “suspect product” and “illegitimate product” in
FDA Policy/General
Federal Register notice: FDA is seeking comments on post-marketing pediatric-focused safety reviews of products posted between 10/23/2017 and 3/16 on its Web site but not being presented at an upcoming 3/23 Pediatric Advisory Committee meeting. The reviews are mandated by the Best Pharmaceuticals for
Drugs
An FDA review of cancer drugs that used the accelerated approval program has found that very few of the resulting indications failed to verify clinical benefit in required confirmatory trials. The review covered the past 25 years and concluded with high marks for the program, according to agency officials writing
Drugs
CDER Office of Strategic Programs director Theresa Mullin has been promoted effective 3/5 to a new position in Center director Janet Woodcock’s immediate office — associate director for strategic initiatives. In her new role, Mullin will oversee “strategic interest” areas that involve external stakeholders. She will continue to lead
Devices
FDA has cleared a Corindus Vascular Robotics 510(k) for what the sponsor says is the first automated robotic movement designed for its CorPath GRX platform for use in percutaneous coronary and percutaneous vascular procedures. The device uses the company’s proprietary software feature called “Rotate on Retract” that allows
Drugs
Pending right-to-try legislation in Congress, which would give terminally ill patients access to investigational drugs, is an ill-advised political stance that would “circumvent” FDA’s authority and offer patients false hope, according to an online post from Friends of Cancer Research chair and founder Ellen V. Sigal.
FDA Policy/General
Draft Guide on Product Tracing Standardized Data Federal Register notice: FDA makes available a draft guidance on “Standardization of Data and Documentation Practices for Product Tracing.” 03/02/2018 Guide on Genomic Sampling and Managing Data Federal Register notice: FDA makes available a guidance entitled “E18 Genomic Sampling and Management
Devices
FDA has given 510(k) clearance to the Cardiovascular Systems’ OrbusNeich 1.0mm Sapphire II Pro coronary balloon. The company says it is the first and only 1.0mm coronary balloon available in the U.S.
Devices
A CDRH and CBER proposal on Voluntary Malfunction Summary Reporting Program for manufacturer reporting of certain device malfunction medical device reports (MDRs) has gained the backing of device industry trade group AdvaMed and drawn criticism from women’s health advocates. The proposed program is intended to streamline malfunction reporting and
Drugs
FDA has issued a safety alert about unapproved products claiming to prevent, treat or cure influenza. “As the flu continues to make people sick — and even cause deaths — unscrupulous actors may also be taking advantage of unsuspecting consumers by promoting their fraudulent products that have not been reviewed by the
Drugs
Biogen and AbbVie have announced the worldwide withdrawal of Zinbryta (daclizumab)for relapsing multiple sclerosis (MS) due to safety concerns, including reports of severe liver damage and immune-related conditions. The companies said that “characterizing the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward
Drugs
President Donald Trump wants the federal government to bring lawsuits against pharmaceutical companies that may have used false, deceptive or unfair marketing practices to help fuel the U.S opioid abuse crisis. Speaking at a 3/1 White House summit on opioid addiction, Trump said he raised the issue with
Devices
FDA has cleared an Alfa Scientific Designs 510(k) for its Simple Cup multi-drug test with Driven Flow, a multi-drug of abuse urine test. The urine immunoassay identifies 13 drugs or drug metabolites and it yields results in two minutes while maintaining line integrity for at least two
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Standardization of Data and Documentation Practices for Product Tracing.” The document discusses the standards for the interoperable exchange of transaction information, transaction history, and transaction statements (product tracing information) provided under the drug supply chain security provisions of the
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “E18 Genomic Sampling and Management of Genomic Data.” The International Council for Harmonization guidance focuses on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data in clinical studies. It is intended to provide harmonized
Drugs
FDA has accepted for review a Jazz Pharmaceuticals NDA for solriamfetol, an investigational drug for treating excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. The agency has set a user fee review action target date of 12/20. The submission includes data from a Phase 3 clinical
FDA Policy/General
Federal Register notice: FDA has announced a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting is scheduled to provide information and solicit input on current
Drugs
Attorneys David Gibbons and Dara Levy (Hyman, Phelps and McNamara) say that FDA interpretations of regulations on importation of active pharmaceutical ingredients (API) are driving manufacturing of investigational finished drug products outside the U.S. In a post in their firm’s FDA Law Blog, the two write that under
Drugs
FDA has posted an International Council for Harmonization guidance “E18 Genomic Sampling and Management of Genomic Data.” The document is intended to provide harmonized principles for genomic sampling and managing genomic data in clinical studies. It also is structured to facilitate the implementation of genomic studies by enabling a common