Search Results for FDA guidance

Showing 1 – 25  of 34

Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance By Zachary Brennan - Published 12 January 2017

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar names, non-proprietary biologic naming, biologic names, FDA guidance

180-Day Exclusivity for Generics: FDA Releases Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: 180-day exclusivity, generic drugs, FDA guidance

Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry on the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: endpoints, clinical trials, clinical guidance, FDA guidance

CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming By Zachary Brennan - Published 11 January 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: interchangeability, FDA guidance, guidance agenda, CDER guidance

FDA Offers Final Guidance on CGMP Requirements for Combo Products By Zachary Brennan - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first released in January 2013.

Categories: News, US, FDA, Combination products, Regulatory intelligence, Regulatory strategy

Tags: CGMP, combo products, FDA guidance

Updated: FDA Offers Draft Q&A on Reporting Requirements for Wholesalers, Third-Party Logistics Providers By Zachary Brennan - Published 09 January 2017

The Food and Drug Administration (FDA) on Tuesday will release draft question-and-answer guidance, supplementing another draft from 2014, to help drug wholesale distributors and third-party logistics understand their annual reporting requirements.

Categories: News, US, FDA, Distribution, Drugs, Labeling, Packaging

Tags: DSCSA, wholesale drug distributor, drug logistics, FDA guidance

FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars By Zachary Brennan - Published 03 January 2017

Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Due Diligence, Government affairs

Tags: clinical pharmacology data, biosimilars, reference products, FDA guidance

Top Ten Stories From 2016 by Traffic By Zachary Brennan - Published 23 December 2016

Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading!

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: 2016 top 10 list, Brexit, Trump, FDA guidance

Electronic Informed Consent: Final Q&A Spells Out New Recommendations By Zachary Brennan - Published 14 December 2016

The Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) on Wednesday finalized a question and answer (Q&A) guidance on using electronic systems to obtain informed consent for both HHS-regulated human research and FDA-regulated clinical investigations of medical products.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: electronic informed consent, eIC, medical research and informed consent, informed consent and FDA guidance

FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section By Zachary Brennan - Published 08 December 2016

The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Crisis management, Drugs, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: DSCSA, track and trace, supply chain pharmaceuticals, FDA guidance

FDA Finalizes Contract Manufacturer Quality Arrangement Guidance From 2013 By Zachary Brennan - Published 22 November 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on contract manufacturer quality agreements.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Government affairs, Manufacturing

Tags: contract manufacturers, CMOs, FDA guidance

FDA Finalizes Guidance on Generic Drug Facility Self-Identification By Zachary Brennan - Published 22 September 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance on information regarding what companies need to self-identify as a producer of generic drugs and what information they must provide to FDA.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Government affairs, Manufacturing

Tags: GDUFA, generic facility self-identification, FDA guidance

Microbial Vectors Used for Gene Therapy: FDA Offers Final Guidance By Zachary Brennan - Published 16 September 2016

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research this week issued final guidance for investigation new drug (IND) submissions for microbial vectors used for gene therapies (MVGTs) in early-phase clinical trials.

Categories: News, US, CBER, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: gene therapies, FDA guidance, IND guidance

FDA Finalizes Two Medical Device Guidelines By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform benefit-risk determinations.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: FDA guidance, medical device guidance, benefit-risk determinations of devices

Chewable Tablets: Companies Seek Clarity on FDA Draft Guidance By Zachary Brennan - Published 19 August 2016

Pfizer, AstraZeneca, Bayer, Genentech and Shire, among others, are seeking more clarity from the US Food and Drug Administration (FDA) on draft guidance covering the critical quality attributes drugmakers should consider when developing chewable tablets.

Categories: News, US, FDA, Clinical, Compliance, Drugs, Manufacturing, Quality

Tags: chewable tablets, chewable drugs, pharmaceutical comments on FDA guidance, FDA draft guidance

FDA to Reclassify Pharmaceutical Co-Crystals By Zachary Brennan - Published 16 August 2016

As part of an effort to clarify and help advance the development of pharmaceutical co-crystals, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance providing information on the appropriate classification of co-crystal solid-state forms, the data that should be submitted to support the classification and the regulatory implications of such a classification.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical co-crystals, salts, polymorphs, FDA guidance

FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions By Zachary Brennan - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance clarifying how it plans to determine cases when real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions.

Categories: News, US, FDA, Clinical, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: real-world data, device and real world evidence, device registries, FDA guidance on real world data

FDA Finalizes Guidance on Adaptive Designs for Device Studies By Zachary Brennan - Published 26 July 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance that lays out how to design medical device clinical trials that allow for changes based on data, while maintaining study validity and integrity.

Categories: News, US, FDA, Due Diligence, Medical Devices, Research and development

Tags: adaptive trial designs, device clinical trials, final FDA guidance

FDA to Restrict Compounders from Making Copies of Commercially Available Drugs By Zachary Brennan - Published 07 July 2016

The US Food and Drug Administration (FDA) on Thursday issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Over the counter drugs, Prescription drugs, Manufacturing, Quality

Tags: drug compounding, FDA guidance on compounding

FDA Offers New Draft Guidance on How Device Manufacturers Can Share Data With Patients By Zachary Brennan - Published 09 June 2016

As patients increasingly play a more active role in their own healthcare, the US Food and Drug Administration (FDA) on Thursday issued new draft guidance to clarify that medical device manufacturers may share patient-specific information recorded, stored, processed, retrieved and/or derived from a device that helps to treat or diagnose that patient.

Categories: News, US, FDA, Compliance, Labeling, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: medical device guidance, data sharing with patients, FDA guidance

70 Groups Call on FDA to Revert Back to Meaningful Suffixes for Biosimilar Names By Zachary Brennan - Published 12 May 2016

The fight over how biosimilars should be named in the US isn’t over yet despite the US Food and Drug Administration’s (FDA) use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: biosimilar names, Zarxio, meaningful suffixes for biosimilars, FDA guidance

Human Factors Review: FDA Outlines Highest Priority Devices By Zachary Brennan - Published 02 February 2016

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to inform medical device manufacturers which device types should have human factors data included in premarket submissions, as well final guidance from 2011 on applying human factors and usability engineering to medical devices.

Categories: News, US, FDA, Clinical, Due Diligence, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Quality, Research and development

Tags: FDA guidance, human factors data, medical device user interface

New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA By Zachary Brennan - Published 06 December 2015

Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Preclinical, Project management, Quality, Regulatory strategy, Research and development, Submission and registration

Tags: FDA-sponsor meetings, FDA guidance, IND guidance, drug application guidance, FDA and pharma industry communications

FDA Revises Draft Guidance on Certification Process for Medical Gases By Zachary Brennan - Published 24 November 2015

The revisions on the 2012 draft guidance on the certification process for medical gases includes new discussions on the labeling for final use containers and what documentation is necessary for marketers of a medical gas that are not the original manufacturer or marketer.

Categories: News, US, FDA, Compliance, Distribution, Drugs, Due Diligence, Government affairs, Medical Devices, Quality

Tags: medical gases, FDA guidance, revised draft guidance, oxygen, nitrogen, carbon monoxide

FDA Releases Final Guidance on Integrated Summary of Effectiveness By Zachary Brennan - Published 07 October 2015

More than seven years since unveiling the draft document, the US Food and Drug Administration (FDA) on Wednesday finalized its guidance on how an Integrated Summary of Effectiveness (ISE) should be prepared for new drug applications (NDAs) and biologics license applications (BLAs).

Categories: News, US, FDA, Biologics and biotechnology, Prescription drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ISE guidance, BLA, NDA, drug effectiveness, FDA guidance