Search Results for Zachary Brennan

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AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices By Zachary Brennan - Published 27 September 2016

Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Pfizer, AdvaMed, benefit-risk guidance for medical devices, FDA draft guidance

Industry Weighs in on FDA Draft Guidance on Infectious Disease NGS-Based Diagnostics By Zachary Brennan - Published 27 September 2016

Diagnostic companies Illumina, Roche, AstraZeneca and others are offering a peek inside how they view next-generation sequencing (NGS) diagnostic devices, with the release of 20 comments on recent US Food and Drug Administration (FDA) draft guidance.

Categories: News, US, FDA, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: Illumina, Roche, AstraZeneca, next-gen sequencing, infectious disease diagnostics

EMA and FDA Set Up New Working Group on Rare Diseases By Zachary Brennan - Published 26 September 2016

The new collaboration between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced Monday will improve the sharing of information on various aspects of the development and scientific evaluation of medicines for rare diseases.

Categories: News, Europe, US, EMA, FDA, Drugs, Government affairs

Tags: rare disease, FDA and EMA collaboration, rare disease cluster

GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process By Zachary Brennan - Published 26 September 2016

On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering eight-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Manufacturing

Tags: ANDA backlog, generic drug reviews, generic competition

Biomarkers Used as Outcomes: FDA Wants to Hear More on Examples By Zachary Brennan - Published 26 September 2016

The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in the development of FDA-approved new molecular entities and new biologics.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs

Tags: biomarkers, biomarker examples, clinical trial biomarkers, FDA and biomarkers

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

Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls By Zachary Brennan - Published 22 September 2016

Congress and President Barack Obama have one week to reauthorize the pediatric priority review voucher (PRV) program, which will sunset on 30 September 2016 after seven pediatric PRVs have been awarded, one of which sold for $350 million last year.

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

Tags: priority review vouchers, PRV, pediatric PRV, Sarepta, Janssen, Alexion

FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance By Zachary Brennan - Published 22 September 2016

Although the Food and Drug Administration (FDA) has continued to say that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar, interchangeability, BsUFA

Regulatory Recon: FDA’s Califf Calls for Sarepta Trial Retraction; Alzheimer’s Drug Fails in Phase III Study (22 September 2016) By Zachary Brennan - Published 22 September 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, MHRA, NICE, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

CDRH Outlines Top 10 Science Priorities for 2017 By Zachary Brennan - Published 21 September 2016

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) plans to leverage real-world evidence and more “Big Data” for more regulatory decisions, according to a list of its science priorities for 2017.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices

Tags: CDRH, device priorities, real-world data for devices

Regulatory Recon: Genentech Bets $310M on Cancer Vaccine Tech; Global Pledge on Superbugs (21 September 2016) By Zachary Brennan - Published 21 September 2016

Welcome to Regulatory Reconnaissance. Today’s edition comes to you as the Focus team returns from Regulatory Convergence. Hope you had a good conference.

Categories: News, Asia, Europe, US, EMA, FDA, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (20 September 2016) By Zachary Brennan - Published 20 September 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CFDA, PMDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: Thai FDA, Skynet, Australia expedited pathways, CFDA on generics

Destination Cuba: Regulator Prepares for Influx of Novel US Pharmaceuticals By Zachary Brennan - Published 20 September 2016

With the restoration of diplomatic relations betweeen the US and Cuba in late 2014, the island is prepping for a wave of new and generic US pharmaceuticals and biologics, the head of the Havana-based regulatory agency, known as the Center for State Control of Drugs, Medical Devices (CECMED), told Focus in an exclusive interview.

Categories: News, Latin America and Caribbean, US, EMA, FDA, ICH, WHO, Biologics and biotechnology, Drugs

Tags: Cuba, Cuba embargo, lung cancer vaccine Cuba, Cuba drug regulations

Sarepta Wins Controversial FDA Approval for First DMD Drug By Zachary Brennan - Published 19 September 2016

The US Food and Drug Administration (FDA) on Monday approved Sarepta Therapeutics’ first drug to treat patients with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness in young children.

Categories: News, US, FDA, Drugs

Tags: Sarepta Therapeutics, DMD, eteplirsen, FDA approval of DMD drug

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

EMA’s CHMP Recommends Ban of US CMO’s Medicines By Zachary Brennan - Published 16 September 2016

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that medicines manufactured by Maryland-based contract manufacturing organization (CMO) Pharmaceutics International (Pii) should no longer be available in the EU, except for Ammonaps (sodium phenylbutyrate), which is used to treat a rare disease and is considered critical for public health.

Categories: News, Europe, US, EC, EMA, FDA, MHRA, Crisis management, Drugs, Government affairs, Manufacturing, Quality

Tags: Pharmaceutics International, CHMP, US contract manufacturing of drugs

Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance? By Zachary Brennan - Published 16 September 2016

The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via ClinicalTrials.gov, though it remains to be seen if the $10,000 per day penalties from the US Food and Drug Administration (FDA) will be strictly enforced.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Drugs

Tags: clinical trials, final NIH rule, clinical trial transparency, FDA penalties, clinicaltrials.gov

FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb’s Cancer Treatment Opdivo By Zachary Brennan - Published 15 September 2016

The US Food and Drug Administration (FDA) this week agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications for renal cell carcinoma, metastatic melanoma and non-small cell lung cancer. 

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Labeling

Tags: Opdivo, Bristol-Myers Squibb, Opdivo dosing

New House, Senate Bills Would Require Companies to Justify Drug Price Hikes of More Than 10% By Zachary Brennan - Published 15 September 2016

US Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ), as well as Rep. Jan Schakowsky (D-IL), on Thursday introduced new bills that would require drug manufacturers to disclose and provide more information about planned drug price increases, as well as data on research and development costs.

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

Tags: drug prices, Schakosky, Tammy Baldwin, John McCain, drug price transparency

Total Kidney Volume Qualified as a Biomarker by FDA for ADPKD Trials By Zachary Brennan - Published 15 September 2016

The US Food and Drug Administration (FDA) on Thursday released new guidance providing a qualified context for use for the biomarker total kidney volume (TKV) in studies for the treatment of the common, life-threatening genetic disease known as autosomal dominant polycystic kidney disease (ADPKD).

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

Tags: ADPKD, biomarkers, FDA qualification of biomarkers

FDA Offers New Guidance on Qualified Biomarker for COPD Trials By Zachary Brennan - Published 14 September 2016

The US Food and Drug Administration (FDA) on Wednesday issued guidance providing details on the qualified context of use (COU) for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality.

Categories: News, FDA, Clinical, Drugs

Tags: COPD clinical trials, qualified biomarkers

Regulatory Recon: Bayer to Buy Monsanto for $66B; House Oversight Committee to Grill Mylan’s CEO Next Week (14 September 2016) By Zachary Brennan - Published 14 September 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Europe, US, FDA, Health Canada, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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 Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date By Zachary Brennan - Published 14 September 2016

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is calling on Durect and Pain Therapeutics to pull promotional materials on their websites for their unapproved Remoxy (oxycodone) extended-release capsules as the websites incorrectly suggest that the investigational new drug is safe and effective.

Categories: News, US, FDA, Clinical, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: opioid, Durect, Pain Therapeutics, Pfizer, abuse deterrant opioids

FDA to Hold One Advisory Committee for Each Initial Biosimilar By Zachary Brennan - Published 13 September 2016

The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each first new biosimilar for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar advisory committee, critical quality attributes