Drugs
An NIH Covid-19 treatment guideline panel has refuted FDA’s recent decision to grant an Emergency Use Authorization (EUA) for convalescent plasma for treating of hospitalized patients with Covid-19. The panel 9/1 reviewed available evidence from published and unpublished data on convalescent plasma, including the FDA analyses
Drugs
Mylan has recalled four lots of amiodarone HCl injection, USP 450 mg/9 mL, and tranexamic acid injection, USP 1000 mg/10 mL due to potential labeling mix-ups between the lots. The individual vials contained within the cartons are accurately labeled as amiodarone HCl or tranexamic acid, a recall
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should clarify that patents claiming the device constituent of a drug-device combination product approved in an NDA or a component thereof are drug product patents subject to Orange Book listing requirements. PhRMA states its position in its response to an
FDA Policy/General
Federal Register notice: FDA has determined that KV Pharmaceuticalֺ’s Micro-K LS (potassium chloride) extended-release liquid suspension, 20 milliequivalents/packet, was not withdrawn for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are
FDA Policy/General
Federal Register notice: FDA is correcting a 5/14 Federal Register notice on 16 NDA withdrawals from multiple applicants. The document indicated that FDA was withdrawing approval of NDA 050641, Aqua Pharmaceuticals’ Monodox (doxycycline monohydrate). Aqua has informed FDA that it did not want the NDA approval withdrawn. To view
FDA Policy/General
Federal Register notice: FDA has established a public docket to collect comments related to post-marketing pediatric-focused safety reviews of products posted between 9/23/2019 and 9/1/2020 but not being presented at a 9/15 Pediatric Advisory Committee meeting. Submit either electronic or written comments by
Drugs
FDA has denied two of three issues raised in a 1/14/2013 petition filed by the law firm of Kleinfeld, Kaplan and Becker. The petition asked that the agency (1) reconsider and rescind the 5/16/2012 510(k) clearance for the GeNOsyl MV-1000; (2) require NDA approval
Devices
FDA says that of four scenarios described in a Becton Dickinson (BD) 6/30 recall of its BD Alaris infusion pump system, three of the scenarios are Class 1 and one is Class 2. The classifications are included in a recall update. BD said it initiated the recall to notify
Drugs
President Donald J. Trump said 9/1 he would be meeting later this week with drug company representatives to discuss his recent executive order that would, among other things, require Medicare to tie prices it pays for drugs to those paid by other countries. Reuters reports that a spokesperson for
Drugs
A 2/24-2/28 FDA inspection at the Mylan drug manufacturing facility in Sangareddy District, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). An 8/20 Warning Letter says specific deviations were: * failing to have adequate cleaning procedures to prevent contamination or
Drugs
A 12/17/19-1/7/20 FDA inspection at Acella Pharmaceuticals, Alpharetta, GA, found significant violations of current good manufacturing practice (CGMP) and other regulations in the firm’s production of finished drugs. An 8/14 Warning Letter says the firm’s NP Thyroid drug product is an unapproved
Drugs
Novo Nordisk responds to an FDA draft guidance, Orange Book Questions and Answers, with the observation that the agency does not address the status of authorized generic applications in its answer to a question about which applications are not listed in the Orange Book. The company says that those not
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) identifies two reasons supporting the recent HHS announcement that FDA will no longer conduct premarket review of laboratory-developed tests (LDTs). Writing in his firm’s FDA Law Blog, Shapiro says the reasons are that: * clinical laboratories will no longer be under the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Acella Pharmaceuticals, Alpharetta, GA, (8/14): FDA inspected the firm in January and found significant GMP violations for finished drugs. For example, Acella failed to establish laboratory controls that
Drugs
An assessment of combination product review practices under PDUFA 6 indicates that the practices are generally considered by the product sponsors and agency reviewers to be effective and efficient despite some challenges. The just-released 8/7 assessment by Lexington, MA-based Eastern Research Group, Inc. says: * request for determination
Drugs
Timothy Baxter, the former global medical director of Indivior (formerly Reckitt Benckiser) pleaded guilty in a Virginia federal court to a one-count misdemeanor information charging that he caused introduction into interstate commerce of the misbranded drug Suboxone Film. The company’s former CEO recently entered a guilty plea to
Drugs
FDA has issued a guidance, Control of Nitrosamine Impurities in Human Drugs, recommending steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The document also describes conditions that may introduce nitrosamine impurities. FDA says the
Drugs
FDA commissioner Stephen Hahn needs to hold a press conference and tell the truth about how he was pressured to misrepresent (see earlier story) the effectiveness of convalescent plasma or resign, according to widely acclaimed researcher and Scripps Research Translational Institute director Eric Topol. In an open letter to Hahn,
Drugs
Attorneys General from 23 states and territories are asking FDA to prohibit the use of the Orange Book to block competition. Montana attorney general Tim Fox said the Orange Book “enables the branded drug manufacturer to obtain an automatic 30-month suspension of FDA’s approval of any potential generic
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Innate Pharma’s Lumoxiti (moxetumomab pasudotox-tdfk), indicated for treating adult patients with relapsed or refractory hairy cell leukemia who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Adverse Experience Reporting For Licensed Biological Products; and General Records—21 CFR Part 600” (OMB Control Number 0910-0308). The collection supports FDA-issued adverse experience reporting requirements in part 600 (21 CFR part 600) to enable
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. FDA says patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as scientific evidence to support regulatory and healthcare