FDA Policy/General
Federal Register Final rule: FDA is amending 21 CFR 17.2 to remove the maximum civil money penalties table associated with statutory provisions authorizing civil money penalties under the FD&C Act or the Public Health Service Act. This information will be included in the HHS regulations. The agency
Drugs
Novo Nordisk has recalled six batches of its GlucaGen HypoKit due to two customer complaints involving detached needles on the syringe with sterile water for injection. The product is indicated for treating severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. “Untreated hypoglycemia can eventually
Drugs
A Jazz Pharmaceuticals citizen petition asks FDA not to approve any generic applications that reference its Xyrem (sodium oxybate) oral solution if they carve out labeling about a drug interaction with divalproex sodium. The petition also asks the agency not to approve any generic Xyrem that does not include the
Drugs
Emmaus Life Sciences has submitted an NDA for its orally administered pharmaceutical grade L-glutamine (PGLG) for treating sickle cell disease. If approved, the drug would be the first treatment for pediatric patients, and the first potential new treatment in nearly 20 years for adults. Emmaus is requesting a priority
Devices
FDA has cleared a Carestream 510(k) for the OnSight 3D Extremity System, which uses cone beam computed tomography technology to capture weight-bearing and other types of extremity exams. “Our extremity imaging system can help in treating a host of orthopaedic conditions that affect the biomechanical behavior of the
Drugs
United Exchange Corp. (Cerritos, CA) has recalled five lots of its Family Care Eye Wash due to microbial contamination. The company learned of the potential issue after receiving a product complaint. “Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a
Drugs
FDA has posted an International Conference (ICH) on Harmonization draft guidance on “General Principles for Planning and Design of Multi-Regional Clinical Trials” that describes how best to design drug trials so as to increase their data’s acceptability in multiple regulatory jurisdictions. The document addresses strategic program issues as
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information “Postmarket Surveillance — 21 CFR Part 822,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA seeks comments on recordkeeping requirements related to the medical devices current good manufacturing practice quality system regulation. The CGMP/QS regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies requirements for verifying/validating production processes and process
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the charter of the Oncologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 9/1/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA has determined that Prevacid IV (lansoprazole) intravenous injection, 30 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the agency to approve ANDAs for lansoprazole intravenous injection, 30 mg/vial, if all other legal and regulatory requirements are
Drugs
The “Cancer Moonshot” Blue Ribbon Panel has issued a report with 10 recommendations it says could lead to significant advances in the understanding of cancer and how to intervene in its initiation and progression. The Blue Ribbon Panel included cancer researchers, oncologists, patient advocates, and representatives from government and the
Devices
The FDA Medical Device Single Audit Program (MDSAP) Regulatory Authority Council is inviting medical device manufacturers to participate in the regulatory single audit program. An online invitation says an MDSAP pilot opened 1/1/14 and is the implementation of an International Medical Device Regulators Forum MDSAP initiative. The transition
Drugs
A tripartite meeting last week between FDA, European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency shared information on data requirements for approving new antimicrobial agents under limited circumstances (limited number of patients, limited therapeutic tool, targeting single species). The regulatory agencies agreed that a robust response to
Drugs
Republican leaders of the House Energy and Commerce Committee say it’s time for FDA to stop delaying and “pursue thoughtful, Constitutionally-sound solutions that will provide certainty for the future” in terms of appropriate off-label communication. In an online blog post, the leaders note that FDA announced in
FDA Policy/General
Critics say that the FDA Office of Criminal Investigations invests thousands of hours pursuing foreign imported, mislabeled drugs, but too often the cases do not result in prosecution. A lengthy Reuters investigative report finds that prosecutors decline to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent,
Drugs
Vanda Pharmaceuticals is asking FDA not to approve an ANDA referencing its Fanapt (iloperidone) until expiration of the three-year exclusivity covering changes made to the Fanapt labeling for which the company says that a clinical study relating to maintenance treatment was essential. Fanapt is approved for treating schizophrenia in
Drugs
The Biosimilar Working Group of the International Pharmaceutical Regulators Forum (IPRF) has published for comment a “reflection paper” proposing principles on the extrapolation of indications in the authorization of biosimilar products. (FDA is a member of the IPRF.) The paper suggests that the extrapolation of indications of a biosimilar product
Drugs
Tonix Pharmaceuticals says that preliminary topline results from its Phase 3 AFFIRM study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg in patients with fibromyalgia failed to achieve statistical significance in its primary efficacy endpoint of the proportion of patients who reported a 30% or greater reduction
Devices
FDA says it has extended to 9/24/18 the compliance date for Unique Device Identification (UDI) label and Global Unique Device Identification Database submission requirements for certain Class 2 medical devices. An agency notice says that the affected devices include (1) collections of two or more different devices packaged
Drugs
Evoke Pharma says it is preparing a 505(b)(2) NDA for Gimoti (metoclopramide), indicated for relieving symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The product is based on the company’s patented nasal delivery formulation technology. Evoke says it recently met with FDA under a
Drugs
GlaxoSmithKline and Innoviva have released positive data from the pivotal Phase 3 FULFIL study with investigational closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) in patients with chronic obstructive pulmonary disease (COPD). The study was designed to evaluate the effects of once