Devices
FDA has approved a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system. The assay offers a unique, dual-target approach that delivers “accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome,” the
Drugs
FDA has cleared a Hitachi 510(k) for its Real Time Image Gating System for Proton Beam Therapy Systems” for treating cancer patients. The device uses proprietary technology to track and irradiate tumors in motion. “This is accomplished by positioning a gold marker 2mm in diameter, close to the tumor
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for OPKO Health’s Varubi (rolapitant) to be 3,070 days. Of this time, 2,708 days occurred during the testing phase and 362 days occurred during the approval phase. Varubi is indicated in combination with
FDA Policy/General
Federal Register notice: FDA has announced that its Pharmaceutical Science and Clinical Pharmacology Advisory Committee has been renewed for an additional two years beyond the charter expiration date. The new charter will be in effect until 1/22/2020. To view the notice, click here.
FDA Policy/General
Federal Register direct final rule: FDA is amending its general biologics regulations covering time of inspection and duties of inspector requirements. The rule removes outdated requirements and accommodates new approaches, such as a risk-based inspection frequency for drug establishments. The action is part of the Trump Administration’s initiative
Drugs
The Justice Department has issued a memorandum outlining factors that department attorneys should consider when determining whether to seek dismissal of a whistleblower (qui tam) suit under the False Claims Act. The document notes there have been record increases in the number of whistleblower suits over the last few years.
Drugs
FDA has issued Braeburn Pharmaceuticals a complete response letter on an NDA for CAM2038, an investigational buprenorphine weekly and monthly depot injection for treating adults with opioid use disorder (OUD). In the letter, the agency requested additional information before approval could be considered. The company says the agency did not
Drugs
FDA has published a draft guidance, Hypertension: Developing Fixed-Dose Combination Drugs for Treatment, to assist drug sponsors in clinical development of fixed-dose combination drugs for treating hypertension. The guidance focuses on development of two-drug combinations of previously approved drugs, although FDA says the general approach is readily
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” Comments can now be submitted until 3/30. To view the notice, click here.
Drugs
FDA has approved a Synergy Pharmaceuticals NDA for Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. The drug was previously approved for treating adults with chronic idiopathic constipation (CIC). Approval was based on data from the company’s
Devices
FDA says a finalized guidance issued 12/5/17 modified the agency’s categorization of IDE devices used in clinical investigations. A 1/16 Webinar reviewed the guidance and the rationale for the changes. FDAer Ken Skodacek, who works in the CDRH Clinical Trials Program and in the Payer Communication
Drugs
Endo says it is agreeing to an FDA request that it seek a temporary stay of its 10/2017 suit against FDA seeking a declaration that the agency’s interim policy on compounding using bulk drug substances under Section 503B of the 2013 Drug Quality and Security Act (DQSA) is
Devices
Three CDRH staff members are using a JAMA Dermatology editorial to give dermatologists an understanding of each of the different types of PMA (premarket approval) applications for new and modified Class 3 medical devices affecting dermatology. The article notes that with the increased awareness of skin conditions and demand for
Drugs
FDA has granted Synthon Biopharmaceuticals a fast track designation for its investigational anti-HER2 antibody-drug conjugate [vic-]trastuzumab duocarmazine (SYD985). The designation is for treating patients diagnosed with HER2-positive metastatic breast cancer that has progressed during or after at least two HER2-targeting treatment regimens for locally advanced
Drugs
FDA has granted AngioDynamics an expedited access pathway designation for its NanoKnife System and a proposed indication for use in treating Stage 3 pancreatic cancer. Previously, the device was 510(k)-cleared for the surgical ablation of soft tissue. It uses low energy direct current electrical pulses to permanently open
Drugs
FDA and the Federal Trade Commission have posted joint Warning Letters to the marketers and distributors of 12 opioid cessation products. The letters say the companies are illegally marketing unapproved products with claims about their ability to help treat opioid addiction and withdrawal. An FDA statement says the products have
Biologics
FDA has approved a Treos Bio IND for PolyPEPI 1018 to allow a Phase 1 study to proceed with the investigational precision cancer vaccine for patients with metastatic colorectal cancer (mCRC). The study will be conducted at Mayo Clinic in Rochester, Minnesota and University of Pisa in Italy. It will
Drugs
FDA has approved a Perrigo ANDA for a generic version of Allergan’s Estrace Cream (estradiol vaginal cream, USP, 0.01%). It is indicated for treating moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Annual sales of the brand product last year were about $457 million,
Biologics
CBER has issued a revised a Standard Operating Policy and Procedure (SOPP) on “SOPP 8005: Formal Dispute Resolution Process,” which describes the policy for resolving procedural or scientific disputes that cannot be resolved at the review division level between sponsors and CBER review staff regarding submissions under review. The document
Drugs
CDER director Janet Woodcock says that modernizing the new drug review program will be a central theme for the Center in 2018. In a podcast looking ahead to 2018, she says the Center is “looking to react and be able to manage the new science that’s coming forward, all
Drugs
Semler Research Center (SRC), a contract research organization based in Bangalore, India, is suing FDA and some of its inspection and other employees in a California federal court, claiming the agency and its staff violated the company’s Fifth Amendment rights and intentionally inflicted financial distress, interfered with the company’
Drugs
FDA has approved a Shire application for the technology transfer of Cinryze’s (C1 esterase inhibitor [human]) drug product manufacturing process to its Vienna, Austria manufacturing site. This is a second production source for Cinryze, in addition to an undisclosed third-party manufacturer, to meet increased product demand. Cinryze is