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FDA Guidance for Industry: Severely Debilitating or LifeThreatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals

The purpose of this guidance is to assist sponsors in the design of nonclinical studies for the development of pharmaceuticals used to treat patients with severely debilitating or lifethreatening hematologic disorders (SDLTHDs). This guidance is intended to streamline the development of pharmaceuticals used to treat patients with SDLTHDs, other than cancer, while still protecting patients’ safety and avoiding [...]

2019-03-18T22:12:07+00:0019.03.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products

The purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate the effectiveness of drug and biological products. Enrichment is the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is [...]

2019-03-18T21:39:05+00:0019.03.2019|Regulatory Affairs, Training|

UK MHRA: Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal

Leaving the EU with a deal remains the government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario. If the UK leaves the EU on 29 March 2019 without a deal, the following legal obligations will apply to marketing authorisation holders (MAH) in the UK: To operate a [...]

2019-03-18T21:33:02+00:0018.03.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this guidance, defined as ages 12 to 17) in relevant adult oncology clinical trials. FDA recommends the inclusion of adolescent patients in disease- and target-appropriate adult oncology clinical trials to [...]

2019-03-12T20:40:12+00:0012.03.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Evaluation of Devices Used with Regenerative Medicine Advanced Therapies

This guidance provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with FDA’s current thinking regarding evaluation of devices used in the recovery, isolation, or delivery of regenerative medicine advanced therapies. Section 3034 of the 21st Century Cures Act (Cures Act) mandates that FDA issue guidance clarifying how FDA will evaluate devices used [...]

2019-02-19T22:04:27+00:0020.02.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

This guidance provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditions with our recommendations on the expedited development and review of these therapies, including as provided under section 506(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3033 of the 21st Century Cures Act (Cures [...]

2019-02-19T21:57:55+00:0020.02.2019|Regulatory Affairs, Training|

(Cas) FDA Guidance for Industry: Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.This guidance reflects the Agency’s current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine [...]

2019-02-08T19:10:15+00:0008.02.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: The Least Burdensome Provisions: Concept and Principles

The Food and Drug Administration (FDA) is committed to helping patients gain more timely access to new medical devices and to maintaining continued access to existing medical devices that are high quality, safe and effective, by expediting their development, assessment, review, and surveillance, consistent with the Agency’s statutory mission to protect and promote the public health. By streamlining regulatory [...]

2019-02-07T22:00:34+00:0007.02.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

This guidance and the technical specification documents it incorporates by reference describe how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act. In addition to this guidance and existing technical specification documents, further and more detailed technical instructions are included in a separate [...]

2019-01-31T18:15:07+00:0031.01.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection

This guidance provides recommendations to facilitate industry’s development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials. Specifically, this document includes guidance regarding the development and validation of screening assays, confirmatory assays, titration assays, and neutralization assays. For the purposes of this guidance, immunogenicity is defined as the propensity of a [...]

2019-01-29T22:11:26+00:0029.01.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

This guidance is intended to assist applicants in developing the INDICATIONS AND USAGE section of labeling for human prescription drug and biological products that are approved under the accelerated approval regulatory pathway (hereafter accelerated approval) as defined in section 506(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 314, subpart H, or 21 [...]

2019-01-29T21:35:01+00:0029.01.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Data Integrity and Compliance With Drug CGMP

The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics). FDA’s authority for CGMP comes from section 501(a)(2)(B) of the Federal [...]

2018-12-13T20:15:00+00:0014.12.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Questions and Answers on Biosimilar Development and the BPCI Act

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, as well as to describe FDA’s interpretation of certain [...]

2018-12-13T20:10:27+00:0014.12.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Hypertension: Developing Fixed-Combination Drug Products for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. This guidance focuses on development of two-drug combinations of previously approved drugs, although the general approach is readily applicable to three or more drugs in combination. This guidance does not address combinations that include unapproved drug products. [...]

2018-11-12T22:42:01+00:0013.11.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs

This guidance addresses FDA’s current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis (AD). The recommendations in this guidance are based on input received from the March 9, 2015, Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) meeting on this topic [...]

2018-10-08T10:15:04+00:0008.10.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use

This guidance provides industry with the Food and Drug Administration’s (FDA’s) recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers. Specifically, this guidance provides FDA’s revised definitions for single-dose and multiple-dose containers as well as for the new [...]

2018-10-07T18:02:24+00:0008.10.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

This guidance is intended for firms that have registered with the Food and Drug Administration (FDA) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities (outsourcing facilities). Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA “in accordance with the content [...]

2018-10-04T19:42:04+00:0004.10.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a [...]

2018-09-24T18:45:41+00:0025.09.2018|Regulatory Affairs, Training|

EMA: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate – Revision 1

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise [...]

2018-09-19T22:34:35+00:0019.09.2018|Regulatory Affairs, Training|

FDA Guidance for Industry: Nonallergic Rhinitis: Developing Drug Products for Treatment

The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. The guidance discusses issues regarding the definition of a clinical phenotype, trial design, efficacy, and safety for new drug products under development. In particular, the guidance addresses development [...]

2018-09-09T11:00:12+00:0009.09.2018|Regulatory Affairs, Training|