Drugs
The CDER Office of Drug Security, Integrity, and Response has sent Warning Letters to 13 Internet-based companies operating scores of individual Web sites that the agency says are offering unapproved new drugs and misbranded drugs for sale in U.S. commerce. The 13 companies are 247Med, Pharm Cash, Glay
FDA Policy/General
FDA is developing a guidance document on real world evidence (RWE) consensus definitions that is intended to help advance RWE use in pre- and post-market review processes, FDA commissioner Scott Gottlieb told a National Academy of Sciences 9/19 workshop in Washington, DC. The definitions will relate to how
FDA Policy/General
Federal Register notice: FDA is extending the comment period for the public meeting on “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The agency is seeking public input to help ensure that the law’s intended balance between encouraging innovation in drug development and accelerating 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. Firson Co. Chungcheongnam-do, Korea (8/31): FDA inspected the firm 11/2016 and cited it for significant GMP violations for finished pharmaceuticals. Agency investigators determined that the firm
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for a NADA and ANADAs approved during March and April. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents. To view the notice,
FDA Policy/General
Rep. Erik Paulsen (R-MN) believes that reforming FDA is long overdue. Writing in a The Hill opinion piece, the congressman says the agency’s regulatory responsibilities have grown in recent decades and it is suffering from a “top-heavy bureaucracy and an increasingly outdated regulatory model. And, given its
FDA Policy/General
FDA has approved an Ipsen Biopharmaceuticals supplemental NDA for Somatuline Depot (lanreotide) Injection 120 mg for treating carcinoid syndrome. The company says that when used for this indication, the therapy reduces the frequency of short-acting somatostatin analog rescue therapy. Somatuline Depot is also approved for improving progression-free survival
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance #210 entitled “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” The document describes the process for adding a new animal drug to the index, which comprises legally marketed unapproved new animal drugs for minor species that
FDA Policy/General
Federal Register notice: FDA has made available the safety and effectiveness summaries of recent PMAs approved by CBER. Summaries available include Hologic’s Aptima HIV-1 Quant Assay and Roche Diagnostics’ Elecsys HIV Combi-PT. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the rates for prescription drug user fees for fiscal year (FY) 2018. The agency is authorizesd to collect application fees for certain human drug and biological product applications, and prescription drug program fees for certain approved products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced rates for biosimilar user fees for fiscal year (FY) 2018. The agency is authorized to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD); review of certain applications for approval of biosimilar biological products; and each biosimilar
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.” The document is intended to assist developers with refining nonclinical study recommendations for this class of drug given its unique characteristics. It also provides recommendations for a pathway to full drug development
FDA Policy/General
Federal Register notice: FDA has extended until 9/20 the comment period for an 8/14 Federal Register notice requesting feedback about abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances. To view the notice, click here.
FDA Policy/General
Billy K. Groce (Knoxville, TN) has pleaded guilty in the U.S. District Court for Western Virginia to evading FDA veterinary drug regulations. According to a Department of Justice release, evidence showed that Groce operated a business that was created for the purpose of illegally circumventing the agency’s regulation
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.” The document outlines FDA’s recommendations and expectations for evaluating and reporting age, race, and ethnicity data in medical device clinical studies. The primary intent of
FDA Policy/General
Federal Register notice: FDA has announced a “Premarket Approval Application Critical to Quality” pilot program. Participation is voluntary and the program aims to evaluate device design and manufacturing process quality information early in the development process to assist FDA in its review of the PMA manufacturing section and post-approval
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dynavision International West Chester, OH (9/5): FDA inspected the firm in April and determined that its Dynavision D2 product is misbranded because there have been major changes or
Drugs
Researchers at the Oregon Health & Sciences University say that a majority of doctors on Twitter with significant financial conflict (at least $1,000 in general payments in 2014) and frequent tweets (at least 100 total tweets) mention specific drugs for which they have a conflict, and almost none disclose
FDA Policy/General
Federal Register notice: FDA has announced a 10/4 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2018 southern hemisphere influenza season. To view the notice, click here.
FDA Policy/General
FDA Seeks Comments on Reducing Regulation Burden Federal Register multiple notices: FDA seeks comments to help it identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction. 09/08/2017 Workshop on Self-collection Devices for Pap Testing Federal Register notice:
FDA Policy/General
Federal Register multiple notices: As part of the Trump Administration’s “Reducing Regulation and Controlling Regulatory Costs” efforts, FDA is seeking comments to help it identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced to achieve meaningful burden reduction while allowing it to achieve its
FDA Policy/General
The House and Senate have approved a bill that provides funding for FDA and other government agencies until 12/8, as well as emergency disaster funding for damage caused by hurricanes Harvey and Irma. The legislation is now being sent to the president for his signature. While the FY 2018