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FDA Explains How GDUFA II Will Help Small Businesses By Zachary Brennan - Published 26 January 2017

The US Food and Drug Administration (FDA) on Thursday offered more details on how the second iteration of the Generic Drug User Fee Act (GDUFA), which must be approved by Congress and President Donald Trump by the end of September 2017, will improve upon the first.

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

Tags: GDUFA II, generic drug user fees, CMO user fees

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(FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been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

New FDA Drug Approvals: Breaking Down the Numbers By Zachary Brennan - Published 04 January 2017

If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: new drug approvals, pharmaceutical approvals, FDA approval

'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’s Office of New Drugs Director to Retire By Zachary Brennan - Published 05 December 2016

After nearly 25 years of service at the US Food and Drug Administration (FDA), John Jenkins, MD, Director of the Office of New Drugs (OND), will retire from the federal government on 6 January 2017.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Government affairs, Orphan products, Regulatory intelligence, Regulatory strategy

Tags: John Jenkins, Office of New Drugs, OND, CDER's OND, new drug applications

Developing the Next Female Viagra? FDA Offers Draft Guidance With Caveats By Zachary Brennan - Published 25 October 2016

The controversial US Food and Drug Administration (FDA) approval last year of the first drug intended to treat women bothered by a lower sex drive has opened the door for other companies to develop similar drugs.

Categories: News, US, CDER, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Viagra, Addyi, Valeant, low sexual interest, lower sex drive, FSIAD, HSDD

FDA Proposes to Withdraw Two Generic Versions of ADHD Drug Concerta By Zachary Brennan - Published 18 October 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday proposed withdrawing two generic versions of Janssen’s extended-release attention deficit hyperactive disorder (ADHD) drug Concerta (methylphenidate hydrochloride) two years after determining that they do not provide sufficient therapeutic effects.

Categories: News, US, CDER, Crisis management, Generic drugs, Due Diligence, Government affairs

Tags: Mallinckrodt, Lannett Company, FAERS, generic drug approval, extended-release generic drugs

FY 2016 Generic Approvals by FDA: A New Record Under GDUFA By Zachary Brennan - Published 12 October 2016

The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014.

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

Tags: OGD, ANDA approvals, FDA approvals of generic drugs

Woodcock: FDA Hits ANDA Backlog Reduction Goal Ahead of Schedule By Zachary Brennan - Published 11 July 2016

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported on Monday via email that as of 1 July 2016, CDER has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog, thereby accomplishing the agency’s backlog commitment more than one year ahead of schedule. 

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

Tags: GDUFA, ANDA backlog, generic drug user fees

Former FDA Deputy Director Charged With Insider Trading for Leaking Non-Public Approval Information By Zachary Brennan - Published 15 June 2016

A former Deputy Director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) was charged on Wednesday for providing tips on drug approvals to three hedge fund managers that made tens of millions off of the non-public information.

Categories: News, US, CDER, Clinical, Crisis management, Drugs

Tags: FDA, OGD, insider trading, FDA non-public information, securities trading with non-public information

Generic Topical Patches: FDA Offers Draft Guidance on Adhesion Studies By Zachary Brennan - Published 31 May 2016

Generic drugmakers submitting clinical studies on the adhesive performance of a transdermal delivery system (TDS) or topical patch will want to take note of new draft guidance released Tuesday from the US Food and Drug Administration (FDA).

Categories: News, US, CDER, Clinical, Generic drugs, Quality

Tags: drug patch adhesion, generic drug guidance, clinical study design guidance

Pharma Companies: FDA Wants New Info for FY2017 User Fees By Michael Mezher - Published 23 May 2016

The US Food and Drug Administration (FDA) is reminding pharmaceutical companies that they have until 10 June 2016 to submit information FDA needs to prepare invoices for the upcoming fiscal year.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs

Tags: PDUFA, PDUFA V, User fees

FDA Slowly Chips Away at ANDA Backlog By Zachary Brennan - Published 02 May 2016

Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday.

Categories: News, US, CDER, Compliance, Generic drugs, Due Diligence, Government affairs, Submission and registration

Tags: ANDA backlog, generic drug applications, FDA generic approvals

FDA Offers Specific Guidance on Bioequivalence Trials for Next Generation of 38 Generic Drugs By Zachary Brennan - Published 14 April 2016

The US Food and Drug Administration (FDA) on Thursday unveiled 38 new specific recommendations on the types of bioequivalence trials generic drug companies should run in order to win approval for their abbreviated new drug applications (ANDAs).

Categories: News, US, CDER, Clinical, Generic drugs, Government affairs, Preclinical, Research and development

Tags: generic drug, Kalydeco, Entresto, Ibrance Lenvima, cancer drug generics

FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers By Zachary Brennan - Published 08 April 2016

Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection.

Categories: News, China, US, CDER, Combination products, Compliance, Crisis management, Drugs, Due Diligence, Government affairs, Manufacturing, Quality

Tags: China drug manufacturing, Chinese heparin, FDA inspections in China, FDA warning letters for Chinese pharma

Novartis Signs up for Regulatory Training Program as FDA Looks for More Participants By Zachary Brennan - Published 07 April 2016

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is looking for additional participants for its Regulatory Project Management Site Tours and Regulatory Interaction Program as Novartis has already signed on to participate.

Categories: News, US, CDER, Audit, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: regulatory training, regulatory affairs, Novartis, FDA regulatory training

Academic DMD Experts Criticize ‘Errors’ in FDA Ad Com Briefing Documents By Zachary Brennan - Published 21 March 2016

More than 35 medical professors and experts have criticized the US Food and Drug Administration’s (FDA) review of a Duchenne Muscular Dystrophy (DMD) drug, citing errors in the agency’s advisory committee meeting briefing documents.

Categories: US, CDER, Clinical, Crisis management, Drugs

Tags: DMD, Sarepta, eteplirsen, advisory committee briefing documents

FDA to Prioritize Generic Drug Applications for ‘Sole-Source’ Products By Zachary Brennan - Published 14 March 2016

The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic drug submissions for which there is currently only one manufacturer.

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

Tags: generic drugs, generic drug competition, ANDA prioritization, FDA review of ANDAs

FDA’s Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years By Zachary Brennan - Published 14 March 2016

A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies continue to seek more meetings with FDA on specific issues and targeted advice.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Clinical, Compliance, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, FDA work on biosimilars, 351(k), BLA, FDA FTEs

Updated: UK Company Banned From Shipping Medical Devices to US By Zachary Brennan - Published 25 February 2016

The US Food and Drug Administration (FDA) has added UK-based Bedfont Scientific to its import alert list for medical device companies that have not met device quality system requirements.

Categories: News, US, CDER, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Quality

Tags: import alert, Bedfont Scientific, device quality

FDA Advisory Committee Calendar By Tarius - Published 15 February 2017

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Generic drugs, Over the counter drugs, Prescription drugs, Postmarket surveillance

Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees

FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II By Zachary Brennan - Published 28 January 2016

Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told Senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017.

Categories: News, US, CDER, Active pharmaceutical ingredients, Generic drugs, Due Diligence, Government affairs, Manufacturing, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: GDUFA, generic drugs, Janet Woodcock, Senate HELP, ANDA approvals

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

EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record By Michael Mezher - Published 12 January 2016

In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014, granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17.

Categories: News, Europe, EMA, CDER, Biologics and biotechnology, Drugs, Orphan products, Submission and registration

Tags: New active substance, new chemical entity, 2015 approvals, Marketing authorization