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Filtering on: "topics project management"

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Industry Supports FDA Proposal to Create New Office of Patient Affairs By Zachary Brennan - Published 13 June 2017

Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Project management, Regulatory intelligence, Regulatory strategy

Tags: BIO, GSK, TransCelerate, Shire, Office of Patient Affairs, FDA patient engagement

Testing and Implementing a Web-Based, Country Regulatory Information Management System By Elizabeth Rehfeld - Published 13 January 2017

This informal case study highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform.

Categories: Features, Project management, Regulatory intelligence

Tags: Information management, Regulatory information management system

Unifying Best Practices for Managing Regulatory Processes: Part 3 By Jim Reilly - Published 21 December 2016

This article highlights the biggest challenges of a fragmented Regulatory Information Management (RIM) landscape as seen in the eyes of life sciences leaders who report their struggles in uniting disparate processes, systems and data.

Categories: Features, Business Skills, Project management, Regulatory strategy

Companies Collaborate on DSCSA Guideline as Deadlines Approach By Zachary Brennan - Published 22 November 2016

Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Business Skills, Distribution, Drugs, Government affairs, Labeling, Project management

Tags: GS1, traceability, pharmaceutical track and trace, serialization, DSCSA

EMA Sets Deadlines for 2016 Type I Variations By Zachary Brennan - Published 24 October 2016

The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IAIN and Type IA variations, for 2016 by 30 November.

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Project management

Tags: Type I variations, EMA deadlines

FDA Amends Definition of Custom Device By Zachary Brennan - Published 11 October 2016

The Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Categories: News, US, CDRH, Compliance, Government affairs, Medical Devices, Product withdrawl and retirement, Project management, Quality

Tags: custom medical device, device regulations, premarket notification, FDA final rule

For Developers of New Genome Sequencing Analytical Tools, FDA Launches ‘App-a-Thon’ By Zachary Brennan - Published 03 October 2016

The US Food and Drug Administration (FDA) on Monday launched what it’s calling an “App-a-Thon,” inviting software developers to get together and add next-generation sequencing (NGS) software apps to the precisionFDA app library.

Categories: News, US, CDRH, Biologics and biotechnology, In vitro diagnostics, Project management

Tags: precisionFDA, NGS applications, precision medicine

GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info By Zachary Brennan - Published 29 September 2016

Despite recent steps to improve cybersecurity, the US Government Accountability Office (GAO) said Thursday that the US Food and Drug Administration (FDA) needs to better protect industry and public health data.

Categories: News, US, FDA, Business and Leadership, Postmarket surveillance, Project management

Tags: IT security, non-public data and FDA

Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program By Zachary Brennan - Published 23 August 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs

Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition By Zachary Brennan - Published 27 July 2016

The Federal Trade Commission (FTC) on Wednesday announced that generic drugmaker Teva Pharmaceuticals has agreed to sell its rights and assets to 79 pharmaceuticals to settle FTC charges that its proposed $40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anticompetitive.

Categories: News, US, FTC, Crisis management, Generic drugs, Manufacturing, Project management

Tags: Teva, Allergan, generic drugs, generic drug competition

FDA Lowers ANDA Fee Rates for 2017 By Zachary Brennan - Published 26 July 2016

Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Generic drugs, Government affairs, Manufacturing, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: generic drug API manufacturing, GDUFA, generic drug facility fees, FDA fees

The Path to Successful Global Regulatory Operations: Document Management Processes and Technology Challenges By Joe Shepley - Published 12 July 2016

This article discusses the process and technology challenges regulatory operation organizations face as they seek to operate globally and provides recommendations for how they can begin addressing them.

Categories: Features, Business Skills, Drugs, Project management

Tags: Document Management, Process Mapping, Cloud

Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents By Zachary Brennan - Published 11 July 2016

Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s known as the “on sale” bar, according to an opinion released Monday from the US Court of Appeals for the Federal Circuit.

Categories: News, US, Active pharmaceutical ingredients, Drugs, Manufacturing, Project management

Tags: Hospira, Medicines Company, on-sale bar, Federal Circuit

Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed By Zachary Brennan - Published 23 June 2016

The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa.

Categories: News, Africa, WHO, Biologics and biotechnology, Government affairs, Project management, Regulatory intelligence, Submission and registration

Tags: Gavi, PATH, malaria vaccine, GSK, Gates Foundation

FDA Revises Guidance on Special Protocol Assessments By Zachary Brennan - Published 04 May 2016

The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and the US Food and Drug Administration (FDA) to discuss plans for clinical trials.

Categories: News, US, FDA, Clinical, Project management, Regulatory intelligence, Regulatory strategy, Research and development

Tags: SPA, special protocol assessments, clinical trial meetings with FDA

FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling By Zachary Brennan - Published 31 March 2016

The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product.

Categories: News, US, FDA, Biologics and biotechnology, Labeling, Project management, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Research and development

Tags: biosimilar labels, biosimilar approval, reference product labeling

FDA Review Times Steadily Decreasing, Report Finds By Zachary Brennan - Published 29 March 2016

Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group.

Categories: News, US, FDA, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Project management, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: FDA review times, FDA approval trends, breakthrough designations

FDA Science Board Addresses US Opioid Epidemic By Zachary Brennan - Published 01 March 2016

The US Food and Drug Administration’s (FDA) Science Board met Tuesday to discuss pain management and opioid abuse, offering a number of ways to address a topic that’s caught the attention of Congress as overdose deaths mount.

Categories: News, US, FDA, Crisis management, Drugs, Due Diligence, Manufacturing, Postmarket surveillance, Project management

Tags: opioid, heroin, opioid overdose, FDA and opioid, Zohydro, Manchin

New FDA Draft Guidance for Orthopedic Device Developers By Zachary Brennan - Published 11 February 2016

The US Food and Drug Administration (FDA) on Thursday released new draft guidance to help Class II and III orthopedic device developers understand what type of information to include in their submissions for devices using ultrahigh molecular weight polyethylene (UHMWPE) material.

Categories: News, US, FDA, Clinical, Due Diligence, Medical Devices, Packaging, Project management, Research and development

Tags: FDA draft guidance, orthopedic device guidance, UHMWPE

EMA Offers New Draft Guidance on Developing Alzheimer’s Treatments By Zachary Brennan - Published 01 February 2016

The European Medicines Agency (EMA) on Monday released new draft guidance on the development of Alzheimer’s disease treatments that would allow treatments to be evaluated in earlier disease stages before dementia sets in.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Project management, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Alzheimer's disease, dementia treatment, guidance on dementia, Alzheimer's drug development

EMA Will Assess ANSM Review of Botched Clinical Trial in France By Zachary Brennan - Published 19 January 2016

EU authorities could end up revising clinical trial guidelines depending on the outcome of French regulators’ investigation into Biotrial’s halted Phase I trial that has resulted in the death of one volunteer and the hospitalizations of five others.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Ethics, Government affairs, Project management, Research and development

Tags: ANSM, Biotrial, EMA, Bial, clinical trial in France

Proposed Rule Would Revise Regulations on Fixed-Combination Drugs By Zachary Brennan - Published 22 December 2015

The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and co-packaged drugs, as well as to combinations of over-the-counter active ingredients.

Categories: Biologics and biotechnology, Business Skills, Clinical, Combination products, Compliance, Drugs, Ethics, Government affairs, Labeling, Orphan products, Packaging, Preclinical, Project management, Regulatory strategy, Submission and registration

Tags: fixed-combination drugs, FDA rulemaking, proposed FDA rule, OTC drug monographs, nonprescription drug combinations

Congressional Spending Deal Offers $132m More for FDA in 2016 By Zachary Brennan - Published 16 December 2015

As House and Senate lawmakers race to approve a bill to fund the US government for 2016, the US Food and Drug Administration (FDA) should see a slight bump in discretionary funding of $132 million over last year.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Crisis management, Drugs, Government affairs, Manufacturing, Project management, Reimbursement

Tags: omnibus bill. FDA appropriations, Congress spending, FDA budget, FY2016 FDA

NIH Task Force Uncovers Major Issues at Suspended Drug Production Unit By Zachary Brennan - Published 11 December 2015

An internal task force at the National Institutes of Health (NIH) has found “widespread and longstanding” problems at its now-suspended pharmaceutical compounding arm, though the deficiencies were not found to have any direct harm on past or current clinical trial participants.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Crisis management, Distribution, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Project management, Quality, Regulatory intelligence, Regulatory strategy

Tags: NIH, NIH drug manufacturing, FDA inspections, PDS, Francis Collins

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