Search Results for CDER

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Woodcock: CDER Informatics System is Top Priority for 2018 By Michael Mezher - Published 05 December 2017

Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Generic drugs, Over the counter drugs, Prescription drugs, Submission and registration

Tags: 21st Century Cures, Informatics, CDER

FDA Details Plans for More Efficient Inspections, Facility Evaluations By Michael Mezher - Published 24 August 2017

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Inspections, Facility Evaluation, ORA, CDER

When Does CDER Consult With Controlled Substance Staff? Revised MAPP Explains By Zachary Brennan - Published 07 March 2017

The US Food and Drug Administration (FDA) on Monday released a manual of policies and procedures (MAPP) outlining how its Center for Drug Evaluation and Research (CDER) staff consult with Controlled Substance Staff (CSS) on abuse potential and dependence liability.

Categories: News, US, CDER, Drugs, Government affairs

Tags: CDER, CSS, controlled substances, opioids, opioid abuse

CDER Goals for 2017: Improved Informatics, Cures Act Implementation and User Fees By Zachary Brennan - Published 07 March 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock outlined the critical priorities for 2017 in a new podcast as part of what she said will be "another busy and productive year."

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: Woodcock, CDER, FDA priorities, Cures, user fee bills

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(FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been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

'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017 By Michael Mezher - Published 15 December 2016

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Submission and registration

Tags: CDER 2017 Priorities, 21st Century Cures, PDUFA, GDUFA, BsUFA, Janet Woodcock

FDA’s CDER Lays Out Rules for Public-Private Partnerships By Zachary Brennan - Published 09 December 2016

The US Food and Drug Administration (FDA) on Friday published a manual of policies and procedures (MAPP) describing how staff from the Center for Drug Evaluation and Research (CDER) can engage in public-private partnerships and consortia to facilitate, inform, and help the external groups understand CDER’s current thinking in a role separate from any regulatory review process.

Categories: News, US, CDER

Tags: CDER partnerships, public-private partnerships, FDA and non-profits

FDA Calls on Pharma Companies to Join Manufacturing Inspection Program By Zachary Brennan - Published 15 November 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes.

Categories: News, US, FDA, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: OPQ inspections, FDA inspection training, CDER inspections

FDA to Revise Draft Guidance on Quality Metrics Data By Zachary Brennan - Published 12 September 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday offered a couple of revisions to its list of guidance documents for 2016. Most notably, a revision to the agency’s draft guidance on quality metrics is expected later this year.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs, Manufacturing, Quality

Tags: quality metrics, pharmaceutical quality, FDA quality metrics guidance, CDER draft guidance

FDA Makes Drug Safety Labeling Change Information Easier to Access By Zachary Brennan - Published 01 September 2016

The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM), which has created a new database that provides data to the public in downloadable and searchable formats.

Categories: News, US, FDA, Drugs, Labeling

Tags: safety labeling changes, CDER database, MedWatch

FDA’s CDER Unveils Plans for 2016 Guidance Documents By Zachary Brennan - Published 22 January 2016

The guidance agenda for the next fiscal year from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) reveals a lot of new advice on generics, pharmaceutical quality, off-label communications and other recommendations carried over from 2015, particularly on the implementation of the Drug Supply Chain Security Act (DSCSA).

Categories: News, US, CDER, Advertising and Promotion, Clinical, Drugs, Due Diligence, Labeling, Manufacturing, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: CDER guidance, 2016 guidance documents, biosimilar guidance

Biosimilar User Fees: Public Meeting Kicks Off Negotiations for BsUFA II By Zachary Brennan - Published 18 December 2015

The US Food and Drug Administration (FDA) began negotiations on the second biosimilar user fee program on Friday with a public meeting highlighting some of the roadblocks the agency has seen so far and what remains to be done to help make the US biosimilar market more robust.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Quality, Research and development

Tags: BsUFA, biosimilar user fees, biosimilars, follow-on biologics, CDER, CBER, industry

CDER’s Woodcock Outlines Priorities for 2016 By Zachary Brennan - Published 14 December 2015

With a banner year for new drug approvals under its belt in 2015 (42 approvals and counting), the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is now looking at how it can negotiate three new user fee agreements and fill an enormous number of staff vacancies this year.

Categories: News, US, CDER, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Manufacturing, Postmarket surveillance, Quality, Research and development

Tags: CDER, Janet Woodcock, FDA, drug development 2016, drug approvals

Industry Conflicts With FDA: The Options By Zachary Brennan - Published 11 November 2015

Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month.

Categories: News, US, FDA, Active pharmaceutical ingredients, Audit, Biologics and biotechnology, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: FDA, conflict/resolution with FDA, GDUFA, CDER, disputes with FDA, pharma industry disputes, FDA ombudsman

What Causes Variations in Review at CDER? It's All About the Designation By Michael Mezher - Published 21 August 2015

Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Accelerated review, priority review, fast-track designation, breakthrough therapy designation, CDER

What Influences CDER Advisory Committee Members? By Lara Burgess, PhD, RAC, Virginia Cox, JD, Bert Regeer, MD - Published 15 May 2015

Over the past two decades, the US Food and Drug Administration’s (FDA’s) Center for Drug and Evaluation and Research (CDER) has been developing new, expedited pathways to help bring innovative medical products to market more efficiently. These pathways include fast track designation, accelerated approval, priority review and, more recently, breakthrough therapy. Through these expedited pathways, some products have been approved with fewer clinical data than traditionally are required.

Categories: Features, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: CDER Advisory Committee, Advisory Committee, FDA Advisory Committee, CDER Advisory Panel, Influence

FDA Wants Public Input on How to Improve Drug Safety By Alexander Gaffney, RAC - Published 19 March 2015

If you have an idea for what the US Food and Drug Administration's (FDA) pharmaceutical regulators should be working on, now is the time to speak up.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: CDER, SRIG, Safety Research Interest Group

After Months of Silence, FDA Returns to 'Name and Shame' Strategy on Pediatric Trial Compliance By Alexander Gaffney, RAC - Published 22 May 2014

In 2013, the US Food and Drug Administration (FDA) launched a new webpage seemingly intended to shame companies into meeting their pediatric study commitments under the Pediatric Research Equity Act (PREA).

Categories: News, US, CDER, Compliance, Drugs

Tags: PREA, BPCA, PREA Noncompliance Letter, CDER, Pediatric, Clinical Trials

FDA to Spend $1 Million to Develop Mathematic Model of Drug Sameness and Similarity By Alexander Gaffney, RAC - Published 20 May 2014

Drug regulators with the US Food and Drug Administration (FDA) are pursuing the development of new technologies to better understand generic—and perhaps even biosimilar—drugs.

Categories: News, US, CDER, Active pharmaceutical ingredients, Generic drugs, Prescription drugs

Tags: CDER, Algorithm, Generic Drug, Biologic Drug, Pharmaceutical, Generic, Drug, Biosimilar, Study

CDER Launches New Training Tool For International Regulatory Bodies By Alexander Gaffney - Published 27 February 2012

Categories: FDA, CDER, Compliance, Generic drugs

Tags: New Drugs, CDER World, Latest News, regulatory science, pharmaceutical, international, information, training