Drugs
Attorneys Douglas Farquhar and Sara Koblitz (Hyman, Phelps & McNamara) say that while FDA consistently maintains that a complete response letter (CRL) is not a final agency action and thus cannot be appealed in court, a recent case their firm was involved in may have at least opened a way
Drugs
FDA has approved an expanded label for Merck’s Keytruda (pembrolizumab) as monotherapy for treating patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation. Approval is based on data from the Phase 2 KEYNOTE-629 trial that showed an objective response rate of
Drugs
FDA has denied all but one of the requests in a 3/9/15 Celgene/Abraxis BioScience petition asking that the agency refrain from receiving for substantive review or approving any ANDA or NDA that references Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) unless
Devices
FDA has cleared the UVision 360 Luminelle Bx (biopsy) sheath, expanding the capability of the Luminelle DTx system. The company says the sheath, combined with the DTx system, is the first and only integrated directed biopsy device not requiring the use of additional instruments and indicated for uterine and bladder
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Magnetom Free Max, a new High-V magnetic resonance scanner. The company says the device combines a 0.55 Tesla field strength with deep learning technologies and advanced image processing. It is the first 80 cm wide-bore system available,
Drugs
Vifor has petitioned FDA for reconsideration and a stay of certain actions the agency has taken with respect to Venofer (iron sucrose USP) injection that the company says will undermine the public health and are contrary to law. The 6/25 petition arises from FDA’s 5/26 response to
Devices
FDA says in response to an increased availability of domestically-manufactured NIOSH (National Institute of Occupational Safety and Health)-approved N95 disposable respirators, it is revoking the emergency use authorizations (EUAs) of all non-NIOSH-approved disposable respirators, such as KN95s, along with the EUAs for decontamination and bioburden reduction
Drugs
FDA says Teva has recalled one lot of topotecan injection (4mg/4mL) due to the presence of particulate matter. An agency statement says the nationwide recall to the retail/institutional level was initiated based on a complaint from a pharmacy after a single glass particle was observed inside one vial.
Drugs
FDA has issued a guidance, Providing Regulatory Submissions in Alternate Electronic Format, with recommendations on an alternate electronic format for submissions covered under an exemption from or waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act. The recommendations pertain to the format of
Drugs
ChemoCentryx has filed an amendment to its NDA for avacopan for treating anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The submission is intended to address advisory committee concerns that led to a split vote during a 5/6 meeting (see earlier story). The submission triggers a three-month user fee
Drugs
A 9/10-11/5/20 FDA inspection at the Novel Laboratories drug manufacturing facility, doing business as Lupin, in Somerset, NJ, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 6/11 Warning Letter says specific violations were: * failing to establish and follow adequate
Drugs
FDA has issued a draft guidance, Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications, with recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical delivery systems. The document says adhesion performance can affect both safety and effectiveness of transdermal and
FDA Policy/General
7/2/2021 Topical and Transdermal Adhesion Assessments Guide Federal Register notice: FDA has made available a draft guidance entitled Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications. To view the notice, click here. Guide on CNS Cancer Drugs Federal Register notice: FDA has made
Devices
FDA has released a final guidance entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The document is intended to assist labelers and FDA-accredited issuing agencies in complying with UDI labeling requirements. It describes requirements on UDI form and content to help ensure that
Drugs
FDA has issued Provention Bio a complete response letter on its BLA for teplizumab and its use for delaying clinical Type 1 diabetes in at-risk individuals. The letter stated that a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers to compare planned commercial product with
Drugs
CDER director Patrizia Cavazzoni has named Jacqueline Corrigan-Curray to the newly-created position of principal deputy Center director. Since February, Corrigan-Curray has been CDER acting deputy Center director for operations and director of the Office of Medical Policy (OMP). Cavazzoni says she has worked on implementing medical policy
Drugs
FDA has told Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi Syndrome (PWS). CDER’s Division of Diabetes, Lipids and Obesity said that based on data it has seen to
FDA Policy/General
FDA acting commissioner Janet Woodcock says the agency’s FY 2022 budget requests an increase of $185 million “to embark on an effort to upgrade and modernize our physical and technological infrastructure, strengthen our talented workforce, and improve our scientific capability and regulatory structure.” Writing in an FDA Voices online
Devices
The U.S. Court of Appeals for the District of Columbia has vacated an FDA rule that determined that electrical stimulation devices used to treat aggressive or self-injurious behavior present an unreasonable and substantial risk of illness or injury, but only when used to treat aggressive or self-injurious
Drugs
After 20 years at FDA, CDER Division of Therapeutic Proteins director Amy Rosenberg is leaving to join EpiVax as senior director of immunology and protein therapeutics. Rosenberg’s work at the agency was focused on immune tolerance induction and immunogenicity, and she oversaw the regulation and approval of numerous protein
Drugs
A report on FDA’s use of patient-focused drug development (PFDD) in regulatory decision-making calls on the agency to continue to develop and update PFDD guidance and to consider expanding its compendium of clinical outcome assessments (COAs) to delineate not-yet-accepted and accepted patient experience PFDD tools
Devices
FDA says Aquavit Pharmaceuticals is marketing the Aquagold and Advanced Skin Application Platform micro infusion system in the U.S. without marketing clearance or approval. A 6/17 Warning Letter says the products are devices because they are intended for use in the diagnosis of disease or other conditions or