FDA Policy/General
Federal Register notice: CDER has announced a one-day (9/12) public workshop on “Reducing the Risk of Preventable Adverse Drug Events Associated with Hypoglycemia in the Older Population.” The workshop is intended to discuss the importance of individualized glycemic control targets for older patients with diabetes; reducing the risk
FDA Policy/General
Federal Register notice: FDA has announced a 5/9 Science Board meeting that is intended to provide recommendations on the agency’s Innovation Funds work plan as mandated in the 21st Century Cures Act (Section 1002). To view the notice, click here.
FDA Policy/General
Comments Sought on FDA’s Focus Group Use 04/21/2017 Federal Register notice: FDA seeks comments on an information collection on “Focus Groups as Used by the Food and Drug Administration (all FDA- regulated products).” Comments Sought on Dietary Supplement Recordkeeping 04/20/2017 Federal Register notice: FDA asks
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection on “Focus Groups as Used by the Food and Drug Administration (all FDA-regulated products).” The agency wants feedback on whether focus groups are necessary and recommendations to ways to enhance the quality, utility, and clarity of the information
FDA Policy/General
Federal Register notice: FDA has asked for comments on an information collection: “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” Records required by FDA’s regulations in Part 111 provide the foundation for the planning, control, and improvement processes that
FDA Policy/General
AbbVie says FDA’s issuance of a payor guidance and medical products communications guidance are “an important step forward in improving the communication of information that is related to approved uses and consistent with a drug’s PI but that does not appear in that PI or meet FDA’s
FDA Policy/General
The federal government says there are several reasons why the Supreme Court should not hear an appeal filed by Jack and Peter Decoster of their three-month sentence under the Park (responsible corporate officer) doctrine. Attorney Jennifer Thomas (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog
FDA Policy/General
The Senate Health, Education, Labor & Pensions (HELP) Committee has planned a 4/26 vote on Scott Gottlieb to be the next FDA commissioner. Earlier this month, the HELP Committee held a hearing where Gottlieb was grilled about his ties to industry (see earlier story). Gottlieb told members that his
FDA Policy/General
Federal Register notice: FDA has announced a 5/10 Medical Imaging Drugs Advisory Committee meeting that will discuss a NX Development Corp. NDA for 5-aminolevulinic acid hydrochloride for the proposed indication as an imaging agent to assist in real time detection and visualization of malignant tissue during glioma surgery.
FDA Policy/General
Federal Register notice: FDA has announced a 5/24 Oncologic Drugs Advisory Committee meeting that will review two NDAs. In the morning session, panel members will discuss a Puma Biotechnology NDA for neratinib maleate, indicated as a single agent for the extended adjuvant treatment of adult patients with early-stage
FDA Policy/General
Federal Register notice: FDA has announced a 5/25 Oncologic Drugs Advisory Committee meeting that will discuss a Hospira BLA for a proposed biosimilar product referencing Amgen’s Epogen/Procrit (epoetin alfa), indicated for treating anemia due to certain illnesses. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 5/9-10 workshop to obtain input on issues and challenges associated with federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids for health care providers. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA and the Critical Path Institute’s Patient-Reported Outcome Consortium have announced a 4/25 public workshop entitled “Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials.” The workshop is intended to discuss challenges for clinical outcome assessments, particularly patient- reported outcome assessments, in
FDA Policy/General
Federal Register notice: FDA is requesting comments on an information collection for its interim final rule “Medical Devices; Exception From General Requirements for Informed Consent — 21 CFR 50.23.” The information collection requests certain information to allow an exception from the general requirements for informed consent, to permit the use
FDA Policy/General
Faculty members at the Harvard Kennedy School and Washington University School of Law says FDA commissioner-nominee Scott Gottlieb will face five major challenges at the agency once he is confirmed. Writing in a New England Journal of Medicine Perspective, the two list the challenges as: * deciding what evidence should
FDA Policy/General
Federal Register notice: FDA has announced a 5/8-9 Pharmacy Compounding Advisory Committee meeting. During the meeting, panel members will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the committee intends to discuss
FDA Policy/General
Comment Period Extended on Animal DNA Guidance 04/13/2017 Federal Register notice: FDA extends the comment period for the draft guidance for industry #187 “Regulation of Intentionally Altered Genomic DNA in Animals” that was announced in the 1/19 Federal Register. FDA Exempts 71 Class 1 Devices from 510(
FDA Policy/General
The former CEO of Action Packing and Design, Paul Rodriguez, has pleaded guilty to trafficking in counterfeit labels and packaging, according to southern Texas acting U.S. Attorney Abe Martinez. Between 7/2015 and 12/2016, “Rodriguez intentionally trafficked in counterfeit labels and packaging by manufacturing, and then shipping to
FDA Policy/General
Federal Register notice: FDA has extended the comment period for the draft guidance for industry #187 “Regulation of Intentionally Altered Genomic DNA in Animals” that was announced in the 1/19 Federal Register. The extension was made in response to requests for additional time to submit comments. Electronic or written
FDA Policy/General
Federal Register notice: FDA has identified 71 Class 1 devices that are now exempt from premarket notification requirements, subject to certain limitations. The agency believes that the device types are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety
FDA Policy/General
FDA and Emulate have entered into a Cooperative Research and Development Agreement (CRADA) to evaluate and qualify the use of Emulate’s Organs-on-Chips technology as a platform for toxicology testing to meet regulatory evaluation criteria for products. The CRADA studies will use Emulate’s Human Emulation System, which
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Indoco Remedies Ltd. Verna, Goa, India (3/27): FDA inspected the firm’s drug manufacturing facility 9/2016 and cited GMP violations related to its finished pharmaceuticals. For example,