FDA Policy/General
The U.S. Supreme Court 6/24 delivered a 6-3 decision that will make it easier for FDA and other government agencies to shield companies’ supposed commercial/confidential information from disclosure under the Freedom of Information Act (FOIA). Writing in a 6/26 FDA Law Blog post, Hyman, Phelps
Biologics
CBER has released a list of 20 guidances it is considering for development in this calendar year. The notice says the list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 draft
Drugs
FDA has expanded the approval of Regeneron’s Dupixent (dupilumab) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. CRSwNP can be a debilitating condition, with many patients opting for systemic steroids or nasal surgery. The condition alos often
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Clinical Investigations for Prostate Tissue Ablation Devices.” The document provides recommendations for clinical investigations for high intensity ultrasound systems for prostate tissue ablation and new types of prostatic tissue ablation devices. To view the notice, click here.
Drugs
FDA will receive feedback for 60 days on its Clinical Data Summary Report pilot program that is part of an effort to increase the transparency of the clinical data used in the regulatory decision-making process. A Federal Register notice says the agency also wants public feedback on a new
Devices
FDA has published a guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, with recommendations for manufacturers seeking marketing clearance for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, the document describes the types of modifications to a diagnostic ultrasound device for
FDA Policy/General
FDA has released a draft guidance entitled “E19 Optimization of Safety Data Collection.” The document is intended to provide internationally harmonized guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such
Devices
FDA has issued a draft guidance, Clinical Investigations for Prostate Tissue Ablation Devices, with recommendations for (1) complying with the clinical testing special control for 510(k)s for high-intensity ultrasound systems for prostate tissue ablation, and (2) collecting clinical data to support marketing submissions for new types of
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension related to a guidance on “Administrative Procedures for Clinical Laboratory Improvement Amendments (CLIA) Categorization — 42 CFR 493.17 (OMB Control Number 0910-0607)." The guidance describes procedures FDA uses to assign the complexity category to a device,
Drugs
A bipartisan group of House lawmakers has introduced legislation to make more over-the-counter (OTC) medications available to patients. The Over-the-Counter Monograph Safety, Innovation, and Reform Act was spearheaded by Reps. Diana DeGette (D-CO), Bob Latta (R-OH), Debbie Dingell (D-MI) and Brett Guthrie (R-
Drugs
A 1/28-2/1 FDA inspection at Rxhomeo Private Limited, Hyderabad, Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 6/13 Warning Letter says the violations were: * failing to test samples of each component for identity and conformity with all appropriate
Devices
FDA has cleared a Viveve Medical 510(k) for the company’s next-generation Viveve 2.0 cryogen-cooled monopolar radiofrequency system for use in general surgical procedures for electrocoagulation and hemostasis. The company says its device’s controlled cooling protects the tissue surfaces from any damage and impacts the
Biologics
A Florida federal court 6/25 has issued an order that stops U.S. Stem Cell Clinic, of Weston, FL, and U.S. Stem Cell Inc., of Sunrise, FL, and their chief scientific officer Kristin Comella, from manufacturing or distributing any and all stromal vascular fraction products, which are adipose
Drugs
FDA has clarified for small businesses when “research” versus “commercial” should be selected on FDA-1571 and thus when electronic common technical document requirements would apply for an IND application. In a podcast, CDER Office of New Drugs team leader Paul Phillips says a commercial IND is one for which
Drugs
FDA has issued a Warning Letter to Akorn, Inc., relating to a 2018 inspection at its Somerset, NJ, drug manufacturing facility. The company says it “will respond to the FDA letter within the required 15 working days” and “is committed to resolving the Warning Letter in a comprehensive and effective
Drugs
FDA has issued Acer Therapeutics a complete response letter on its NDA for Edsivo (celiprolol) for treating vascular Ehlers-Danlos syndrome (vEDS). The agency letter says it will be necessary to conduct an adequate and well-controlled trial to “determine whether celiprolol reduces the risk of clinical events in patients
Drugs
Bipartisan leaders of the House Energy and Commerce Committee are asking for information from FDA on two agency actions relating to opioids. In a 6/25 letter to agency acting commissioner Ned Sharpless, the legislators raise questions about (1) the agency’s management of safeguards against high-risk patients being
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. International Hospital Products, Littleton, CO (5/29): FDA inspected the firm 3/15-19 and cited GMP violations with its Baker Jejunostomy and intestinal tubes used for bowel decompression.
Drugs
FDA has sent Daiichi Sankyo a complete response letter on its NDA for quizartinib for treating adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Quizartinib, an oral selective Type II FLT3 inhibitor, was approved earlier this month by Japan under the brand name Vanflyta for the same indication.
Devices
A 3/15-3/19 FDA inspection at International Hospital Products, Littleton, CO, found Quality System Regulation violations in the firm’s work as a manufacturer (specification developer) of Class 2 Baker Jejunostomy and intestinal tubes used for bowel decompression. A 5/29 Warning Letter says specific violations were: * failing
Biologics
The Healthcare Distribution Alliance says it commends FDA for issuing a draft guidance on initiating voluntary recalls and the clarity and assistance it offers to recalling firms and their trading partners. It also says the draft is not aligned with Drug Supply Chain Security Act requirements and explains its detailed
Drugs
FDA has approved an Amag Pharmaceuticals NDA for Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. An FDA news release says that HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing