Drugs
Attorneys Sara Koblitz and Kurt Karst (Hyman, Phelps & McNamara) say the Orange Book Modernization Act signed by President Trump 1/5 primarily codifies existing FDA patent listing practices. Writing online in their firm’s FDA Law Blog, Koblitz and Karst say that although there is little new in the
Devices
FDA has issued an immediately-in-effect guidance, Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, to provide a policy to help expand the availability of coagulation systems for measuring whole blood viscoelastic properties that are used to assess
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 27 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposal to make permanent certain medical device regulatory flexibilities provided during the Covid-19 public health emergency by exempting some devices from premarket notification requirements. For seven Class 1 devices for which 510(k) premarket review was temporarily waived during Covid
FDA Policy/General
Federal Register notice: HHS is requiring FDA to publish annually on its Web site the following NDA/ANDA review information: (a) the date on which FDA filed an NDA or received an ANDA; (b) the date on which FDA approved the NDA or ANDA; (c) the total days elapsed between
FDA Policy/General
Using expanded authority granted to it by Congress in the 2018 reauthorization of the Animal Drug User Fee Act, FDA has given the first conditional approval to Pegasus Laboratories’ KBroVet-CA1 (potassium bromide chewable tablet) to control seizures in dogs with idiopathic epilepsy. An agency news release says the drug
Drugs
FDA has cleared a Hyperfine Research 510(k) for its deep-learning image analysis software to measure brain structure and pathology in images acquired by the Swoop Portable MR Imaging System. The analysis software relies on tools featuring automatic measurement of ventricular volume, brain extraction, brain alignment, and midline shift
Devices
Writing in a New England Journal of Medicine Perspective article, three CDRH staffers review new studies on the safety of paclitaxel-coated devices (PCDs) used to treat atherosclerotic peripheral arterial disease (PAD) and call for ongoing data collection. The article discusses questions that have been raised about the devices’ safety
Drugs
FDA has issued an immediately-in-effect guidance, Covid-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity, to assist sponsors in developing monoclonal antibodies and other therapeutic proteins for use as Covid-19 therapeutics. The document says that a critical quality control
FDA Policy/General
FDA has issued a report, FDA Covid-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative: Summary Report, summarizing the insights, supporting facts, and work of the FDA Covid-19 PREPP initiative between 7/2020 and 12/2020. The report describes ongoing and potential prospective actions to strengthen the agency’s
Drugs
PDUFA reauthorization discussions were held by various committees, working groups, and subgroups in five sessions held virtually in October and November 20. Meeting summaries and minutes for each session were released by FDA and show: * FDA/Industry Postmarket Subgroup, 10/28/20 — continued discussions of possible options of common interest
FDA Policy/General
Former CDER director Janet Woodcock, who had been on detail at the White House’s Operation Warp Speed but recently moved to the Office of Commissioner (OC) to serve as principal medical advisor to the commissioner, is the likely choice of the incoming Biden Administration to serve as acting commissioner
FDA Policy/General
Federal Register notice: HHS has issued a final rule to promote transparency and fairness in civil enforcement actions. The regulations will help to ensure that regulated parties receive fair notice of laws and regulations they are subject to, and have an opportunity to contest an agency determination prior to the
Drugs
FDA has granted Timber Pharmaceuticals an orphan drug designation for TMB-003, the company’s locally delivered formulation of sitaxsentan, indicated for treating systemic sclerosis. The condition can be disfiguring and may cover joints and cause pain that affects movement and mobility, the company says. It describes sitaxsentan as a
Drugs
FDA has told Marinus Pharmaceuticals that the efficacy and safety data resulting from the company’s Phase 3 Marigold Study using oral ganaxolone in children and adults with CDKL5 deficiency disorder appear sufficient to support the filing of an NDA. The company says that the adequacy of the data to
Drugs
FDA has granted Leading BioSciences a fast track designation for LB1148 for treating postoperative gastrointestinal (GI) dysfunction associated with pediatric heart surgery. The designation was based on the therapy’s potential to accelerate return of bowel function and reduce the risk of serious and life-threatening complications associated with corrective
Biologics
Operation Warp Speed chief adviser Moncef Slaoui has resigned at the request of the Biden administration, CNBC reports. The cable business network says the controversial former GlaxoSmithKline executive will remain in his role for a month to assist in the transition. Sources tell CNBC that Slaoui’s role in leading
FDA Policy/General
In one of its final actions in the last week of the Trump administration, HHS has issued a final rule it says is “designed to enhance HHS practices involving transparency and fairness in civil enforcement actions.” An HHS press statement (includes a link to the final rule) says the new
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Extralabel Drug Use for Animals — 21 CFR 530” (OMB Control Number 0910-0325). The collection supports the Animal Medicinal Drug Use Clarification Act of 1994, which allows a veterinarian to prescribe the extralabel use of approved new
Drugs
In a 6-3 split on ideological lines, the Supreme Court has granted an FDA request to reinstate a federal requirement that women being prescribed mifepristone for a medical abortion in the early stages of pregnancy have to obtain the pill in person from a healthcare provider and sign a
Devices
Two SheppardMullin attorneys say the quick takeaway from the 1/12 publication of an FDA action plan for artificial intelligence and machine learning (AI/ML) software is that the agency will publish a guidance on change control plans, a key concept from its 4/2020 discussion paper on AI/ML
Devices
Two Hogan Lovells attorneys say FDA will begin accepting Safer Technologies Program (STeP) for Medical Devices requests 3/8. Writing in an online analysis, the attorneys outline the provisions of a 1/6 final guidance describing the voluntary program for medical device and device-led combination products that offer a