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Bioanalytical Method Validation Guidance for Industry

  • Industry: All FDA Regulated Industry

This guidance helps sponsors of investigational new drug applications (INDs) or applicants of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation.2 This guidance can also inform the development of bioanalytical methods used for nonclinical studies that require toxicokinetic or biomarker concentration data. For studies related to the veterinary drug approval process such as investigational new animal drug applications (INADs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs), this guidance may apply to blood and urine BA, BE, and pharmacokinetic studies.

FDA New Guidance on Q-Submission Meetings for Devicemakers- Q-submission process

  • Industry: Medical Devices

On June 7 2018 FDA has released new draft guidance related to meetings devicemakers may request under the agency’s Pre-Submission Program — it is also known as Q-submission meetings as the agency assigns applications a Q number.

 
 
The term “Q-Submission” or “Q-Sub” refers to the system used to track the collection of interactions These are important opportunities for submitters to share information with FDA and receive input outside of the submission of an IDE, IND, marketing submission, or CW. The interactions tracked in the Q-Sub program may be used at different points along the total product life cycle for a device and are voluntary.
 
The draft guidance covers various categories of device-related submissions, - IDE, PMA, HDE, De Novo request, 510(k), Dual,
 BLA, IND , humanitarian device exemptions. it also applies to pre-submission feedback and certain INDs

Final Guidance on Bioanalytical Method Validation - June 2018

  • Industry: Drugs and Chemicals (Pharma)

 On May 22, 2018, the US Food and Drug Administration (FDA) published a final guidance for industry entitled "Bioanalytical Method Validation.” This guidance incorporates public comments to the revised draft guidance that was issued in September 2013, and reflects advances in science and technology related to validating bioanalytical methods. 

FDA’s Good Importer Practices Guidance: What You Need to Know?

  • Industry: Trade and Logistics Compliance

FDA’s Good Importer Practices Guidance: What You Need to Know?

The U.S. FDA, among other several government agencies such as USDA, EPA, U.S. Department of Homeland Security, Customs and Border Protection etc., published a draft guidance on Good Importer Practices (GIP) in 2009. This draft guidance offers general suggestions to the importers on procedures and practices they should follow to ensure that products they import are in compliance with the U.S. safety and security requirements.

FDA Regulations on Social Media and Internet Communications

  • Industry: All FDA Regulated Industry

FDA Regulations on Social Media and Internet Communications

The advancements in the technology and, in particular, the development of the digital technology have made a remarkable impact in the area of communication in the past decade. Nowadays, even the patients and healthcare providers are using social media and other internet sources to get information about FDA regulated products.

Thus the online information provided by the manufacturers and their representatives about the products should be clear, accurate and non-misleading. In line with these requirements, the US FDA, in June 2014, has issued two draft guidance documents concerning the use of social media for promotion and advertising purposes of drug and devices.

Canadian Food Label Regulations: How to Comply with CFIA Requirements?

  • Industry: Food Safety Compliance

Canadian Food Label Regulations: How to Comply with CFIA Requirements?

The central responsibility to set the standards for Canadian food label is shared among two departments, Health Canada and the Canadian Food Inspection Agency (CFIA). While Health Canada is responsible for developing the policies and standards related to the health, safety, and nutritional quality of foods, the Canadian Food Inspection Agency (CFIA) holds the accountability for the administration of food labeling policies related to misrepresentation and fraud.

FDA's Guidance on Pharmaceutical Quality System

  • Industry: Drugs and Chemicals (Pharma)

FDA's Guidance on Pharmaceutical Quality System

The US FDA, in April 2009, has announced the availability of the ICH Q10 guidance on the pharmaceutical quality system. This guidance along with the ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management” are essential for implementing an effective pharmaceutical quality system.

FDA's Guidance on Development and Manufacture of Drug Substances

  • Industry: Drugs and Chemicals (Pharma)

FDA's Guidance on Development and Manufacture of Drug Substances

The US FDA, in November 2012, has announced its adoption of the ICH Q11 guideline on the development and manufacture of drug substances. The guidance explains both the traditional and enhanced approaches in developing and understanding the manufacturing process for a drug substance. It also offer details on the information that should be provided in Module 3 of the Common Technical Document (CTD) sections.

Multi-Regional Clinical Trials: ICH and FDA General Principles for Planning and Design

  • Industry: Clinical Research

Multi-Regional Clinical Trials: ICH and FDA General Principles for Planning and Design

With the increasing globalization of drug development, the use of multi-regional clinical trials (MRCTs) for regulatory submissions has increased. Regulatory authorities in different countries such as Japan, USA, EU and China have issued the guidance documents on MRCTs. ICH has started the process for having a harmonized guidance document on MRCTs and the document is likely to be issued in 2017.

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs)

  • Industry: Drugs and Chemicals (Pharma)

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs)

The quality and the stability of Active Pharmaceutical Ingredients (APIs) are vital for the overall quality, safety and efficacy of human drug products. Thus, APIs for pharmaceutical use and those used for manufacturing drugs for clinical trials are highly regulated. The US FDA has had an extensive set of GMP requirements for APIs for several decades now and still guidelines are continually being revised.

ANDA Submissions: FDA Revised Refuse-to-Receive Guidance

  • Industry: Drugs and Chemicals (Pharma)

ANDA Submissions: FDA Revised Refuse-to-Receive Guidance

The US FDA has recently revised its guidance on standards for refuse-to receive (RTR) an abbreviated new drug application (ANDA). The updated guidance not only offers a broader definition for major deficiencies and but also downgraded four major deficiencies to minor ones to make requirements less cumbersome for industry.

FDA Issues Final Guidance on the Use of Electronic Informed Consent

  • Industry: Clinical Research

FDA Issues Final Guidance on the Use of Electronic Informed Consent

The informed consent process has been an area of debate over the past few years. Regulations and guidelines controlling the conduct of clinical trials require informed consent to be obtained from each study subject prior to initiation of clinical investigation. In December 2016, FDA published its final guidance on the use of electronic informed consent. This guidance document finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” published in March 2015.

FDA ANDA Submissions Guidance - Prior Approval Supplements under GDUFA

  • Industry: Drugs and Chemicals (Pharma)

FDA ANDA Submissions Guidance – Prior Approval Supplements under GDUFA

US FDA has issued a guidance, in October 2016, to aid pharma companies preparing to submit prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the FD&C Act. The guidance further explains how the GDUFA relates to PAS submissions. Specifically, the guidance focuses on the following key areas:

FDA Releases New Final Guidance on Medical Device Reporting Requirements for Manufacturers

  • Industry: Medical Devices

FDA Releases New Final Guidance on Medical Device Reporting Requirements for Manufacturers

The US FDA has recently finalized its 2013 draft guidance on the Medical Device Reporting (MDR) requirements for manufacturers. The guidance supersedes the 1997 MDR guidance document. The finalized guidance document addresses the reporting and recordkeeping requirements for device related adverse events and malfunctions.

The guidance requires the submission of three types of MDR reports. These include 30-day (initial) reports [21 CFR 803.10(c). 803.20 and 803.50], 5 - day reports [21 CFR 803.10(c), 803.20 and 803.53] and supplemental reports [21 CFR 803.10(c) and 803.56]. It further details the required information to be included in the each kind of report and the necessary time frame for submissions.

Food Labeling Guide

  • Industry: Food Safety Compliance

Food Labeling Guide

Under the FDA's jurisdiction, the FD&C Act (Federal Food, Drug, and Cosmetic Act) and the Fair Packaging and Labeling Act govern regulations for food products. To ensure that the food sold in the US is wholesome, safe and adequately labelled with nutritional information, the FDA seeks to offer insight to industry participants through this guidance.

While the guidance does not cover the entire gamut of questions that may arise with relation to food labelling, it does address the key issues and questions that constantly surface in the industry.

FDA Draft Guidance on Referencing Approved Drugs in ANDA Submissions

  • Industry: Drugs and Chemicals (Pharma)

FDA Draft Guidance on Referencing Approved Drugs in ANDA Submissions

The process for obtaining approval to market a generic drug varies from the process of gaining authorization to market a novel drug under new drug application. The Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD &C) authorizes an applicant to submit FDA an abbreviated new drug application (ANDA) to seek approval for marketing of the generic drugs.

The FDA has recently issued a draft guidance that clarifies these generic drug manufacturers on how to define and use several terms in ANDA submissions.

Small Business Guide to FDA

  • Industry: All FDA Regulated Industry

Small Business Guide to FDA

FDA's regulations seek to prevent, or at the very least mitigate, health risks that slowly began to emerge over a century ago – with the industrialization of the production of food and pharma products. Over a period of time the Agency’s responsibilities came to be defined under about 200 federal laws.

While it becomes a challenge to stay updated with these complex laws, it is nevertheless mandatory for businesses that manufacture, sell, transport, warehouse, or import any FDA-regulated product.

FDA Guidance on Assessment of Drugs Abuse Potential

  • Industry: Drugs and Chemicals (Pharma)

FDA Guidance on Assessment of Drugs Abuse Potential

The abuse potential of a drug is a vital consideration in the development of a new drug. Physicians and healthcare providers need to know if the new drug is expected to be abused after approval and marketing to assure the protection of public health. Assessing drug abuse potential also provides the basis for controlling and regulatory actions related to drug control.

As a component of the safety evaluation of the new drug, FDA has recently finalized the guidance to aid investigational drug sponsors in assessing whether their new drug has abuse potential. According to this guidance, if the drug substance is CNS active and produce adverse effects such as hallucinations, the drug is likely to undergo detailed assessment of its abuse potential and is subjected to control under the Controlled Substances Act (CSA).

How to Comply with FDA cGMP Requirements for Phase 1 Investigational Drugs?

  • Industry: Drugs and Chemicals (Pharma)

How to Comply with FDA cGMP Requirements for Phase 1 Investigational Drugs?

The phase I of a clinical trial involves the initial introduction of the investigational new drug (IND) into the human beings. Consequently, it is important to regulate these studies to ensure patient safety. The FDA guidance outlines the current good manufacturing practices (cGMP) for most of the investigational drugs used in phase 1 clinical trials.

FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices

  • Industry: Medical Devices

FDA Guidance on Postmarket Management of Cybersecurity in Medical Devices

The significant technological advancements in medical device in today’s world has laterally increased the risk of cybersecurity breaches that could affect device’s performance and functionality. Hence, medical device manufacturers are required to consider cybersecurity throughout the product lifecycle, including during the research and development, design, production, distribution, and maintenance of the device.

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