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EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. 'We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,' says the Executive Director Professor Guido [...]

FDA Guidance for Industry: Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

The purpose of this guidance is to provide information to assist sponsors in the design of an appropriate nonclinical program for the development of radiopharmaceuticals to treat cancer — also known as oncology therapeutic radiopharmaceuticals — and to provide recommendations for certain aspects of product labeling. For the purpose of this guidance, a therapeutic radiopharmaceutical [...]

2019-08-08T19:44:17+00:0008.08.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Vulvovaginal Candidiasis: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the overall clinical development program and clinical trial designs to support drugs for treating vulvovaginal candidiasis (VVC). In general, this guidance focuses only on treating VVC. This guidance does not discuss clinical development programs focused on preventing or reducing the recurrence of VVC. Sponsors should [...]

2019-08-08T19:39:09+00:0008.08.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Bacterial Vaginosis: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the overall development program and clinical trial designs to support development of topical and systemic drugs and biological products for the treatment of bacterial vaginosis (BV). This guidance focuses on considerations that are specific to BV drug development. This guidance does not contain discussion of [...]

2019-08-08T19:35:42+00:0008.08.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated urinary tract infections (uUTIs). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of [...]

2019-08-08T19:29:58+00:0008.08.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Risk Evaluation and Mitigation Strategies: Modifications and Revisions

This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS. Specifically, this guidance provides information, as described in section 505-1(h) [...]

2019-07-15T20:38:35+00:0015.07.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect

This guidance describes the Food and Drug Administration’s (FDA, we, or the Agency) policy concerning the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan (also known as 5-hydroxytryptophan or [...]

2019-07-15T20:17:15+00:0015.07.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” This guidance describes policies that FDA intends to use in evaluating bulk drug substances [...]

2019-06-18T20:20:08+00:0018.06.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: ANDA Submissions — Content and Format of Abbreviated New Drug Applications

This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance details the information that should be provided in each section of the common technical document (CTD) format for human [...]

2019-06-17T22:15:11+00:0017.06.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis

The purpose of this guidance is to provide to sponsors nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products (including small molecules and monoclonal antibodies), regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the prevention of sexually acquired human [...]

2019-03-25T21:40:34+00:0025.03.2019|Regulatory Affairs, Training|

FDA Guidance for Industry: Pediatric HIV Infection: Drug Product Development for Treatment

The purpose of this guidance is to provide general recommendations on the development of antiretroviral (ARV) drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric (birth to younger than 18 years of age) patients. This guidance is intended to help sponsors understand when it is appropriate to initiate pediatric formulation development and to begin pediatric [...]

2019-03-25T21:31:38+00:0025.03.2019|Regulatory Affairs, Training|

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|