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FDA Hedges: A Proposal to Better Share R&D Risks By Zachary Brennan - Published 19 April 2017

The probability that an investigational drug will succeed in all three phases of clinical trials and win US Food and Drug Administration (FDA) approval is very low. So low, in fact, that a group of economists have written a new paper calling for a system whereby developers could hedge their research and development (R&D) risks by buying options that would pay companies a pre-specified amount in the event that a treatment fails a given phase of the FDA approval process.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Ethics

Tags: R&D risk, pharmaceutical risks, FDA hedges

Updated: Pharma Profits Continue to Dwarf R&D Spending as Pressure Mounts By Zachary Brennan - Published 27 March 2017

With the repeal of Obamacare on life support, the furor over rising prescription drug prices and President Donald Trump’s support for the cause could end up filling the vacant crossroads where bipartisanship meets change.

Categories: News, US, Business Skills, Drugs, Government affairs

Tags: drug company profits, drug prices, R&D spending on pharmaceuticals

22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report By Zachary Brennan - Published 19 January 2017

With a growing interest from industry in exploring alternatives to Phase 3 trials (ie. relying on different types of data and unvalidated surrogate endpoints), the US Food and Drug Administration (FDA) on Thursday released a new report documenting 22 different times drugs, vaccines and medical devices since 1999 saw promising Phase 2 clinical trial results that were not confirmed in Phase 3 trials.

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

Tags: Phase II trials, Phase III trials, pharmaceutical development, R&D

ICH Advances Three Guidance Documents By Zachary Brennan - Published 02 December 2016

The International Council for Harmonisation (ICH) earlier this week advanced two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase.

Categories: News, Africa, Asia, Canada, Europe, US, FDA, ICH, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Q11, Q3C(R6), E6(R1), ICH guidelines, drug manufacturing

Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices By Zachary Brennan - Published 14 September 2016

The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, WHO, Clinical, Distribution, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: UN High-Level Panel on Access to Medicines, UN reports on pharmaceuticals, compulsory licenses, pharmaceutical R&D

FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics By Zachary Brennan - Published 22 June 2016

The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: ISCRs, ICH, eCTD, E2B(R3)

FDA Outlines Policy on Use of Near Infrared Analysis to Test Drug Quality By Alexander Gaffney, RAC - Published 30 March 2015

New guidance issued by the US Food and Drug Administration (FDA) is intended to help pharmaceutical companies use near infrared (NIR) technology to better ensure the quality of their manufactured drug products.

Categories: News, US, CDER, Active pharmaceutical ingredients, Drugs, Manufacturing, Quality

Tags: Draft Guidance, Guidance, NIR, Near Infrared, ICH Q2 (R1)

FDA Launching Pilot Program to Assess Vaccine Safety Reporting Capabilities By Alexander Gaffney, RAC - Published 28 May 2014

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines.

Categories: News, US, CBER, ICH, Biologics and biotechnology, Postmarket surveillance

Tags: US, FDA, CBER, Vaccine, VAERS, ICSR, Adverse Event, E2B (R3), ICH, Pilot Program

ICH Looks to Clarify 'Key Issues' With E2C Adverse Event Reporting Guideline By Alexander Gaffney, RAC - Published 14 April 2014

Categories: ICH

Tags: PAER, DSUR, E2C (R2), E2C, PSUR, PBRER, Q&A, Latest News

Looking to the Future in Regulatory Affairs By Oliver Cox and Siegfried Schmitt, PhD - Published 13 January 2014

There are many strands to consider when looking to the future in regulatory affairs, including regulations, global harmonization efforts, emerging public healthcare challenges and the capital markets.

Categories: Features

Tags: Public Health, Regulatory Harmonization, R&D, Future, regulatory affairs

FDA Releases Guideline Q&A on Nonclinical Safety Studies for Pharmaceuticals By Alexander Gaffney, RF News Editor - Published 26 February 2013

Categories: ICH

Tags: M3(R2)

Perspectives on FDA Review of Medical Devices: Part 2 By Ron Warren, RAC - Published 18 October 2012

The outcome of any US Food and Drug Administration (FDA) submission is never a certainty, but sponsors can enhance their chances of success by optimizing the submission strategy and content, and by minimizing or avoiding the potential submission problems that tend to slow down or prevent the completion of premarket reviews.

Categories: FDA, Technology

Tags: R&D, Approvals, Perspective, innovation, medical device

Perspectives on FDA Review of Medical Devices: Part I By Ron Warren, RAC - Published 18 October 2012

From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. But the US Food and Drug Administration (FDA) has been besieged by critics who claim the agency is a hindrance to innovation and a threat to the US med-tech industry. Are they right?

Categories: FDA, Technology

Tags: R&D, Approvals, Perspective, innovation, medical device

FDA Releases Final ICH Guidance on Genotoxicity Testing and Data Interpretation By Alexander Gaffney - Published 06 June 2012

Categories: FDA, ICH, Preclinical

Tags: Genotoxicity, S2(R1), Latest News, testing, cancer, guidance

Designing Efficient Clinical Trials for Glucose Sensors Focus of Upcoming FDA Meeting By Alexander Gaffney - Published 18 May 2012

Categories: FDA

Tags: Glucose Sensors, Glucose, Diabetes, R&D, Meeting, Latest News, clinical trial, medical device

Report: FDA Increasingly Playing Key Role in Global Health By Alexander Gaffney - Published 01 May 2012

Categories: Africa, FDA

Tags: Global Health Technologies Coalition, GHTC, Neglected Diseases, Vaccines, Global Health, R&D, Regulatory Capacity, Orphan Diseases, Latest News, regulatory

For Terminally Ill Patients, 'Life Spans Shorter Than FDA's Approval Process' Spurs DIY Medicine By Alexander Gaffney - Published 16 April 2012

Categories: FDA

Tags: R&D, DIY, ALS, Latest News, pharmaceutical, development, drug, regulatory

EMA Invites Comments on ICH Risk-Benefit Guidance By Alexander Gaffney - Published 16 April 2012

Categories: EMA, FDA, ICH

Tags: E2C R(2), PBRER, Effiacy, Latest News, safety

ICH Safety Reporting Standard Advanced by FDA By Alexander Gaffney - Published 10 April 2012

Categories: FDA, ICH

Tags: Periodic benefit-rick evaluation reports, E2C (R2), E2C, PBRER, Latest News, pharmaceutical, draft guidance, guidance, drug

Proposed Bill Would Limit Use of Consent Decrees, Settlement Agreements By Alexander Gaffney - Published 06 February 2012

Categories: FDA

Tags: H.R. 3862, Settlement Agreements, Consent Decrees, Coble, Ross, Quayle, Judiciary Committee, Consent Decree, House, Transparency, Latest News

ICH Releases Additional Guidance on Combination Drug Toxicity Testing By Alexander Gaffney - Published 12 January 2012

Categories: EMA, FDA, ICH, MHLW

Tags: Q&A, M3(R2), Latest News, guidance