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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 This guidance incorporates public comments to the revised draft guidance that was issued in September 2013, and reflects advances in science and technology related to validating bioanalytical methods.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 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.

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 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 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.

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.

Assessment of Abuse Potential of Drugs - Guidance for Industry

  • Industry: Drugs and Chemicals (Pharma)

Assessment of Abuse Potential of Drugs - Guidance for Industry

Abuse-Deterrent Opioids (Evaluation and Labeling) - Guidance for Industry

With the intent to assist applicants who seek approval for a new drug, particularly to evaluate the abuse potential of the drug, and to assist sponsors of investigational new drugs, these FDA guidance seek to offer insight into key decision points such as recommended studies in assessing abuse potential, cases when abuse-related studies should be conducted, preparing the NDA submission, NDA review and product labeling related to abuse potential, and the drug scheduling process.

FDA Guidance on cGMP Requirements for Combination Products

  • Industry: Drugs and Chemicals (Pharma)

FDA Guidance on cGMP Requirements for Combination Products

The US regulatory pathway for combination products is not always very clear. As combination products include constituents that would normally be regulated under different types of governing authorities, they raise regulatory, policy, and review management challenges.

US FDA has recently issued a final guidance detailing the cGMP requirements for combination products including drug-drug, drug-device, device-biologic or drug-biologic combination products. The guidance follows the 2013 final rule on cGMP requirements for combination products.

FDA Guidance on Clinical Pharmacology Section of Drug and Biological Product Labeling

  • Industry: Drugs and Chemicals (Pharma)

FDA Guidance on Clinical Pharmacology Section of Drug and Biological Product Labeling

The clinical pharmacology section of the label should provide an information that is understandable and clear to health care professionals who may not have specific expertise in clinical pharmacology. The FDA guidance offers recommendations for preparing the clinical pharmacology section of prescription drug labeling for applicants submitting NDAs, supplements to approved NDAs, ANDAs, biologics license applications (BLAs) and supplements to BLAs.

cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing

  • Industry: Drugs and Chemicals (Pharma)

cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing

This guidance is proposed to aid manufacturers of sterile drug and biological products meet the FDA cGMP requirements when manufacturing these products under aseptic processing. This guidance replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing.

FDA Draft Guidance for Developing Drugs for Early Stage Alzheimer's Disease

  • Industry: Drugs and Chemicals (Pharma)

The draft guidance explains the FDA’s current thinking about the way researchers can identify and select patients with early Alzheimer’s disease, or those who are at risk of developing the disease, for participation in clinical trials.

FDA Guidance: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Mar ....

  • Industry: Drugs and Chemicals (Pharma)

Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.

FDA Releases Guidance For Manufacturers on Drug Shortage Notifications

  • Industry: Drugs and Chemicals (Pharma)

In 2011, according to FDA, as many as 250 drug shortages have been traced, and a total of 195 drug shortages were prevented, as the Agency has taken proactive steps needed to increase available supply for patients in the U.S. The FDA recently released new guidance on how manufacturers can notify authorities on impending drug shortages.

FDA Biosimilars Draft Guidance - Quality Considerations in Demonstrating Biosimilarity to Refer ....

  • Industry: Drugs and Chemicals (Pharma)

On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.

FDA Biosimilars Draft Guidance - Scientific Considerations in Demonstrating Biosimilarity to a ....

  • Industry: Drugs and Chemicals (Pharma)

On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.

Australia Therapeutic Goods Advertising Code 2007

  • Industry: Drugs and Chemicals (Pharma)

In Australia, advertisements for therapeutic goods that are directed at consumers should get approved before broadcasting or publication and must comply with Therapeutic Goods Advertising Code.

The latest version is Therapeutic Goods Advertising Code (TGAC) 2007 which took effect on March 8, 2007.
 

Proposed CMS Rule: Medicare, Medicaid, Children's Health Insurance Programs; Transparency Repor ....

  • Industry: Drugs and Chemicals (Pharma)

The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.

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