FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Postmarketing Safety Reports for Human Drug and Biological Products: Waivers From Electronic Submission Requirements — OMB Control Number 0910–0770.” The rule requires that firms subject to mandatory reporting requirements submit safety reports in an electronic format that
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.” The document applies to, upon patient request, data from devices that are unique to an individual patient or patient’s treatment or diagnosis that has been recorded, stored,
Drugs
A 6/5-6/9 FDA inspection at India’s Kim Chemicals Private Ltd. found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/16 Warning Letter. The inspection also determined that Kim Chemicals manufactures unapproved new drug and misbranded drug products, the
Devices
An FDA safety update says that interim study results through three years from a pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and scaffold thrombosis in patients receiving Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated
Drugs
A 5/8-5/12 FDA inspection at Accelerated Analytical Laboratories, Milwaukee, WI, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/18 Warning Letter. The letter says the inspection found that the firm failed to establish and document the accuracy, sensitivity,
Drugs
FDA says it will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The authorities are located in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK. An FDA announcement says the recognition “marks an important milestone to successful implementation
Drugs
FDA has granted accelerated approval to AstraZeneca’s Calquence (acalabrutinib) for treating adults with mantle cell lymphoma who have received at least one prior therapy. The kinase inhibitor works by blocking an enzyme needed by the cancer to multiply and spread, according to an FDA release. Approval was based on
Devices
CDRH associate director for science and strategic partnerships Suzanne Schwartz says the agency is encouraging medical device manufacturers to proactively update and patch their devices in a safe and timely manner to address cybersecurity threats. Writing in an FDA Voice blog post, Schwartz says the “concept of updates and patches,
Drugs
The New Jersey attorney general and Division of Consumer Affairs is taking comments on a proposed rule to limit payments and gifts from drug manufacturers to licensed providers who are authorized to prescribe medications. Attorney Serra Schlanger (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that
Devices
FDA has cleared an Abbott 510(k) for its Alinity ci-series instruments for clinical chemistry and immunoassay diagnostics. The company says the devices are designed to help labs address modern industry challenges, including aging populations and growing management of chronic diseases and increased access to care, which are driving
Drugs
The Government Accountability Office (GAO) says HHS should better assess the effectiveness of its efforts to expand medication-assisted treatment (MAT) for opioid addiction. In a study report, GAO says HHS has implemented five key efforts since 2015 that focus on expanding access to MAT for opioid use disorders. There
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Accelerated Analytical Laboratories Milwaukee, WI (10/18): FDA inspected the firm in May and cited significant GMP violations with its finished pharmaceuticals. For example, the firm’s contract testing
Devices
Following Internet blog reports that Bayer has enrolled only one patient of the 2,400 needed for a post-marketing study of its controversial Essure birth control device, three House members led by Rep. Rosa DeLauro (D-CT) have asked for a meeting with FDA commissioner Scott Gottlieb to express
FDA Policy/General
Federal Register notice: FDA has announced a public workshop to discuss methodological approaches for those intending to collect patient experience data for submission to FDA for regulatory decision making. FDA says the methods and approaches should ensure that collected data are accurate and representative of the intended population. The agency
Drugs
As part of the Trump Administration’s national public health emergency declaration against opioid abuse, FDA commissioner Scott Gottlieb says the agency is exploring how opioid drug products are packaged, stored and discarded. In an online post, he says public health could be improved if a short-term supply of
FDA Policy/General
Federal Register notice: FDA has determined that EKR Therapeutics’ hypertension drug Cardene SR (nicardipine HCl) extended-release capsule (30 mg, 45 mg, and 60 mg) was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the drug product if
Drugs
FDA has cleared three antimicrobial susceptibility tests (ASTs) for determining the appropriate usage of Melinta Therapeutics’ Baxdela (delafloxacin), a fluoroquinolone indicated in adults for treating bacterial skin and skin structure infections caused by susceptible bacteria. The three ASTs that have been cleared are: Hardy Diagnostics’ Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk)
Drugs
FDA has approved a Janssen Pharmaceuticals supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. The approval is based on data from the EINSTEIN CHOICE clinical study
Drugs
FDA has published an International Council for Harmonization guidance entitled “E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The addendum presents a structured framework to link trial objectives to a suitable trial design and tools for estimation and hypothesis testing. It introduces the
FDA Policy/General
Federal Register notice: FDA has published the following six medical device classification notices: * Clinical chemistry and clinical toxicology devices — De novo classification of Astute Medical’s Nephrocheck Acute Kidney Injury Test System. * Immunology and microbiology devices — De novo classification of Quidel Corp.’s Lyra Direct Streptococcus SPP Nucleic Acid-Based
FDA Policy/General
Federal Register notice: FDA has reopened the comment period to allow additional time for comments related to a workshop on “Voluntary Medical Device Manufacturing and Product Quality Program.” Comments can be submitted on or before 12/14. To view the notice, click here.
Drugs
FDA says its lab findings again link Rugby Diocto’s oral liquid docusate sodium to Burkholderia cepacia. The contamination was confirmed in several bottles of Rugby Diocto (docusate sodium) oral liquid from lot No. 20351701 manufactured by PharmaTech (Davie, FL). The lot was collected by FDA in response to a