The guidance describes the types of TV ads that FDA intends to be subject to this provision, explains how FDA will notify sponsors that an ad is subject to the requirement of review under section 503B, and describes the general and Center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with section 503B of the FD&C Act.
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The Food and Drug Administration’s (FDA’s) advisory committees play an essential role in FDA’s activities to protect and promote public health through the regulation of human and animal drugs, biological products, medical devices, foods, and tobacco products. FDA’s advisory committees provide independent expert advice and recommendations to the Agency on scientific, technical, and policy matters related to FDA-regulated products. Advisory committees enhance FDA’s ability to protect and promote public health by ensuring FDA has access to such advice through the public hearing process as provided in existing laws and regulations.
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Posted in FDA, regulatory, report
This guidance is intended to help the public, Food and Drug Administration (FDA) advisory committee members, and FDA staff to understand and implement statutory requirements and FDA policy regarding public availability of information about financial interests and waivers granted by FDA to permit individuals to participate in advisory committee meetings subject to the Federal Advisory Committee Act (FACA) (5 U.S.C. App.2). This guidance describes the basis and provides a format for public disclosure of certain financial interests by special Government employees (SGEs) and regular Government employees participating in these advisory committee meetings, and provides a format for FDA waivers allowing participation in these meetings. This guidance also explains how and when these documents will be made publicly available by FDA.
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This guidence document provides to you, sponsors of an investigational device exemption application (IDE) or an Investigational new drug application (IND), recommendations about certain information that should be included in a submission describing a product intended to repair or replace knee cartilage.For the purposes of this document, a product intended to repair or replace knee cartilage, as with other cartilage repair or replacement products, may include a biologic, device, or combination product whose components would individually be regulated by the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER).
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Posted in biotechnology, devices, licensing, manufacturing
Section 6004 of the Patient Protection and Affordable Care Act requires that manufacturers and authorized distributors of record (ADRs) submit certain drug sample information to the secretary of the U.S Department of Health and Human Services no later than April 1st of each year, beginning on April 1st, 2012 (see 42 U.S.C. 1320a-7i). The Secretary has delegated authority to the Food and Drug Administration (FDA or Agency) to, among other things, issue guidance to identify the information to be submitted under section 6004 and to oversee and make arrangements for the collection of such information.
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The increasing globalization of clinical trials presents challenges to both U.S. and foreign regulators, many of which are detailed in the OIG reports.This guidance document is part of FDA’s overall efforts to strengthen oversight of foreign clinical trials. Specifically, FDA is issuing this guidance as part of its efforts to encourage sponsors and applicants to standardize information relating to foreign clinical trials in their INDs and applications for marketing approval.
This guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The questions and answers (Q&As) are grouped by Biosimilarity or Interchangeability, Provisions Related to Requirement to Submit a BLA for a “Biological Product” and Exclusivity.
Posted in biotechnology, business, report
Tagged biologics, biosimilar, BLA, BPCI, FDA
This is one in a series of guidance documents intended to assist sponsors and applicants making regulatory submissions to the Food and Drug Administration (FDA) in electronic format. It establishes FDA’s recommendation that sponsors and applicants submit study data in a standardized electronic format. This guidance also applies to submissions of clinical and nonclinical study data within investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), investigational device exemptions (IDEs), biologics license applications (BLAs), premarketing notifications (510(k)s), and premarketing approval applications (PMAs), including original submissions, amendments, and supplements, to the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH).
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Posted in devices, FDA, market access, regulatory
Tagged electronic-standardized, FDA, regulatory
The purpose of this guidance document is to educate regulated industry and FDA Staff on how, when and why to use classification product codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). Classification product codes are used in a variety of FDA program areas to regulate and track medical devices. This document is limited to medical devices as defined in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act.
Posted in biotechnology, manufacturing, regulatory, report
This guidance is intended to help producers of Positron Emissions Tomography (PET) drugs meet the requirements for FDA’s drug approval process. This guidance provides questions and answers that adress nearly all aspects of the drug regulatory process, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.
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This guidance is applicable to all INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or otherwise under Title 21 Code of Federal Regulations, Part 312 (21 CFR Part 312). This guidance is not applicable to LBPs intended as gene therapy vectors, to oncolytic bacteria, or to oncolytic viruses.2 This guidance also does not apply to products lawfully marketed as conventional foods or dietary supplements that are proposed for investigation solely to evaluate an LBP’s use in affecting the structure or any function of the body (see sections 201(g)(1) and 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(g)(1), 343(r)(6)).
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This guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of human subjects enrolled in clinical investigations. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research.
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Posted in clinical, guidence, regulatory, report
This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’S) current thinking on the potential human health riscks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). The recommendations in this guidance do not address the use of DBP or DEHP in other types of FDA-regulated products or exposure to DBP or DEHP due to the presence of any of these compounds as an impurity—including as a result of leaching from packaging materials.
For further details, please view the document below.
Posted in Diagnostic, guidence, regulatory, report
Tagged CDER, DBP, DEHP, FDA, regulatory
This guidance provides applicants preparing or submitting new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research’s current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads)
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Posted in Drug Development, guidence, regulatory, report
This guidance is a representation of the FDA’s current thinking how manufacturers and distributors of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off label information).
This updates previous guidance and clarifies FDA’s policies, in light of emerging electronic media.
Full guidance reproduced below:
Posted in marketing, regulatory
Tagged FDA, information, off label, provision, unsolicited
The FDA is provided guidance to assist sponsors in developing vaccine to protect against global infectious diseases. The guidance focuses on development of licence of vaccines for infectious diseases or conditions endemic in areas outside the United States. It aims to clarify regulatory status and guidance already published for development of these products.
Full guidance given below
Posted in clinical, pre-clinical
Tagged FDA, global, guidance, infectious disease, vaccine development
This Excel file contains change history and the breakdown of our questions submitted on eCTD structure and specifications.
This file should be viewed in Excel and can be downloaded from the FDA website
Posted in regulatory
Tagged eCTD, electronic common technical dossier, FDA, M2, specification
This guidance is being developed for applicants of new drug application is an abbreviated drug applications in order to give them an insight into the agency’s current thinking on the classification of co-crystal solid-state forms. It also provides information about the data that should be submitted to support the appropriate classification and the regulatory implications of classification.
Full guidance given below
This guidance is intended for blood establishments the manufacturer whole blood and blood components including source plasma and source leucocytes. It provides guidance for the re-qualification method or process for the re-entry of deferred donors who test repeatedly reactive for hepatitis B surface antigens, confirmed positive by neutralisation, following a recent vaccination for hepatitis B infection, and who are not infected by hepatitis B virus.
Full guidance given below
Posted in biotechnology, market access
Tagged blood donor, FDA, hepatitis B, screening, vaccination
The FDA is provided this guidance in order to make recommendations to industry for describing the nonclinical late radiation toxicity studies to determine potential late radiation effects of therapeutic radiopharmaceutical agents. This is to help minimise the risk of late occurring radiation toxicities in clinical trials. Other guidance are available for conventional non-safety studies but this guidance focuses solely on late radiation safety concerns that are unique to therapeutic radiopharmaceuticals. The unique safety concerns result from the risk of irreversible toxicity when these agents deliver high dose of ionising radiation to normal organs.
full guidance given below
Posted in pre-clinical
Tagged FDA, late radiation, Nonclinical, safety evaluation, therapeutic radiopharmaceuticals
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