Drugs
FDA has approved Genetech’s Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A without factor VIII inhibitors. The company says Hemlibra is the only prophylactic treatment for people with hemophilia A and without factor VIII inhibitors
Drugs
Retired Canadian health researcher Saeed Qureshi is asking FDA to withdraw guidances and related recommendations about assessments of drug dissolution characteristics of drug products such as tablets and capsules. In a 10/1 petition, Qureshi asks for removal of three specific guidances from 1997, 2017 and 2018, and the dissolution
Devices
Unplug the Robot member Jennifer Nelson, who says she has had to have multiple surgeries and other procedures in an effort to repair damage caused by a DaVinci Robotic permanent cautery instrument, is petitioning FDA to “seriously revisit and reconsider the issue of banning and recall of all permanent cautery
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.” The document provides recommendations on the selection of appropriate package type
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” The document describes a change in FDA’s current thinking on what constitutes a 505(q) petition. In
Devices
CDRH has released a list of 11 final and 10 draft guidance topics (A-List) that it intends to publish this fiscal year. The post also includes a list of five final and two draft guidances (B-List) that will be published as resources permit, and a list of 20
Drugs
GlaxoSmithKline says it is revising its policy on working with healthcare professionals to allow payments to some doctors who promote company products. “This policy update is being made to ensure we continue to operate responsibly and improve how we help prescribers to understand new data and clinical experience with our
Drugs
FDA has cleared a CarboFix in Orthopedics 510(k) for the CarboClear Carbon Fiber Transverse Connectors to be used in conjunction with its Carbon Fiber Pedicle Screw System, a device used to surgically treat oncological patients. The device, according to the company, offers enhanced radiation therapy planning abilities, allowing radiation
Drugs
Liveyon has recalled all ReGen Series stem cells due to reported adverse reactions. Liveyon distributes umbilical cord derived products to physicians for use in regenerative medicine therapies. Users are being instructed not to use any vials in possession, according to a recall notice.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.” The document addresses how early in drug development applicants should incorporate pediatric patients when (XXX SUBSTITUTE XXX)developing systemic drugs for atopic dermatitis (AD). To view the notice, click
Drugs
FDA has granted VistaGen Therapeutics a fast track designation for AV-101, a non-opioid, non-sedating treatment for neuropathic pain. The investigational, orally bioavailable, small molecule NMDA (N-methyl-D-aspartate) receptor glycine B antagonist is designed to work without psychological or sedative side effects, the company says. AV-
Devices
A 3/19-6/11 FDA inspection at Datascope Corp., Fairfield, NJ, found Quality System regulation and Medical Device Reporting regulation violations in the firm’s manufacturing of the Sensation Plus 8Fr intra-aortic balloon catheter, Mega 7.5 Fr intra-aortic balloon catheter, Sensation Plus 7.5 Fr intra-
Drugs
FDA commissioner Scott Gottlieb says a new revised draft guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, will allow for a more efficient approach to 505(q) petitions and allow the agency to focus more reviewer
FDA Policy/General
Federal Register notice: FDA has announced an 11/8 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to hear an overview of a research program in CBER’s Laboratory of DNA Viruses. To view the notice, click here.
Drugs
Eli Lilly plans to submit an NDA for Ultra Rapid Lispro (URLi) in 2019 after reporting favorable clinical trial data from two Phase 3 trials that it says met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog (insulin lispro) and also demonstrated significantly improved
FDA Policy/General
Federal Register notice: FDA has issued a draft guidance entitled “The Special 510(k) Program” to clarify existing policy and expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. It includes certain changes to the indications for use and clarifies the
FDA Policy/General
Federal Register notice: FDA has issued an order to debar Richard M. Fleming for 10 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases the order on a finding that Fleming was convicted of two felonies under federal
Drugs
A 2/12-2/28 FDA inspection at N-Molecular (doing business as SOFIE and SOFIE Biosciences), Haverhill, MA, found significant violations of current good manufacturing practice regulations for positron emission tomography (PET) drugs. A 9/24 Warning Letter says the specific violations were: * failing to take appropriate corrective action
Drugs
FDA has released a guidance entitled “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.” The document addresses FDA’s current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis.
Drugs
FDA has issued a guidance, Selection of Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use, with the agency’s recommendations on selection of appropriate package type terms and selection of appropriate discard statements
Drugs
A review of 41 clinical trials conducted under the FDA exception from informed consent (EFIC) pathway shows that the pathway has been important for the completion of emergency trials and should aim to optimize respect for patients and public trust. A report from Harvard Medical School researchers published online by
Drugs
The Justice Department says that Amerisource Bergen Corp. (ABC), one of the nation’s largest wholesale drug companies, will pay $625 million to resolve allegations arising from its operation of a facility that improperly packaged oncology-supportive injectable drugs into pre-filled syringes and improperly distributed the syringes to doctors