FDA Policy/General
Federal Register notice: FDA has announced a 1/11/2018 public workshop entitled “Safety Assessment for IND Safety Reporting.” Convened under a cooperative agreement between the agency and the Duke-Robert J. Margolis Center for Health Policy, the workshop is intended to discuss a variety of topics related to an
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Records; Electronic Signatures OMB Control Number 0910-0303.” The agency’s regulations establish criteria for accepting electronic records, electronic signatures, and handwritten signatures executed to electronic records as being equivalent to paper records. Under the regulations,
FDA Policy/General
Guide on Generic Abuse-deterrent Opioids Federal Register notice: FDA makes available a guidance entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.” 11/22/2017 Panel to Review Clarus Therapeutics Testosterone Replacement Federal Register notice: FDA announces a 1/9/2018 Bone, Reproductive
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.”’ The document recommends studies, including comparative in vitro and pharmacokinetic studies, that a potential ANDA applicant should conduct and submit to FDA to demonstrate that a
FDA Policy/General
Federal Register notice: FDA has announced a 1/9/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting in Hyattsville, MD. Panel members will discuss a Clarus Therapeutics NDA for testosterone undecanoate capsules, indicated for testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone:
FDA Policy/General
Federal Register notice: FDA has announced a 2/7-8/2018 public workshop entitled “Tenth Annual Sentinel Initiative Public Workshop” to discuss a variety of topics on active medical product surveillance. It is also intended to provide an understanding of how to use the Sentinel System’s tools to address
FDA Policy/General
Stakeholders are responding with agreement and objection to an FDA request for information and comment on its proposal to change requirements for the content of the so-called major statement that outlines prescription drug risks in direct-to-consumer (DTC) broadcast ads. The National Association of Broadcasters says the agency
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that an Amherst Pharmaceuticals Web page for Zolpimist (zolpidem tartrate) oral spray and Magna Pharmaceuticals’ convention exhibit panels for Zolpimist make false or misleading claims and/or representations about the risks associated with the drug’s efficacy. An 11/14 Warning
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hubei Danjiangkou Danao Pharmaceutical Co. Danjiangkou, Hubei Province, China (11/6): FDA inspected the firm in August and cited significant GMP deviations with its active pharmaceutical ingredients (API). For
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “513(g) Request for Information OMB Control Number 0910-0705.” Section 513(g) of the Federal Food, Drug, and Cosmetic Act discusses how sponsors obtain the agency’s views about the classification and regulatory requirements that may
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its guidance on “Notification of the Intent To Use an Accredited Person Under the Accredited Persons Inspection Program OMB Control Number 0910-0569.” The voluntary third-party inspection program is applicable to manufacturers of Class 2 or
FDA Policy/General
The House Commerce Subcommittee on Health has announced an 11/30 hearing on “Implementing the 21st Century Cures Act: An Update from FDA and NIH.” The hearing intends to examine the law’s implementation as its one-year anniversary approaches. The 21st Century Cures Act is intended to accelerate the
FDA Policy/General
Federal Register notice: FDA has extended its comment period provided in a 7/31 Federal Register notice entitled “Cardiac Troponin Assays; Public Workshop; Request for Comments.” That notice announced the public workshop and requested comments by 11/28; FDA is extending the public workshop’s comment period by 30 days
FDA Policy/General
Federal Register notice: FDA is seeking comments on a petition from an undisclosed applicant requesting exemption from premarket notification requirements for over-the-counter denture repair kits. These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The document provides tissue establishments and health care professionals with FDA’s current thinking on the scope of an exception outlined
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.” The document provides the agency’s current thinking on the regulatory criteria
FDA Policy/General
Federal Register notice: FDA has acknowledged that an applicant for a proposed biosimilar product notified the agency that a patent infringement action was filed in connection with the applicant’s biologics license application (BLA). The notice indicates that Janssen Biotech has filed suit against Celltrion Healthcare (17–CV–11008 in
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Unique Device Identification: Direct Marking of Devices.” This document is intended to clarify when direct marking of devices with a unique device identifier is required, and to assist in understanding direct marking requirements. To view the notice, click here.
FDA Policy/General
Guide on Cell/Tissue-Based Product Regulatory Considerations Federal Register notice: FDA releases a guidance on “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use.” 11/17/2017 Expedited Programs for Regenerative Medicines Draft Guidance Federal Register notice: FDA makes
FDA Policy/General
FDA has released a guidance on “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use.” The document provides the agency’s criterion for determining minimal manipulation and homologous use. It also outlines that over the next 36 months, FDA intends
Drugs
Congresswoman Rosa DeLauro (D-CT) has reintroduced a bill (HR 4385) that would amend the Food, Drug, and Cosmetic Act to restrict direct-to-consumer (DTC) drug advertising. The measure was referred to the House Committee on Energy and Commerce which will consider it before sending it to the House
FDA Policy/General
Federal Register notice: FDA makes available a draft guidance on “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” The draft describes the expedited programs available to sponsors of these therapies for serious or life-threatening diseases or conditions; how CBER will work with sponsors and encourage flexibility in clinical