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Filtering on: "topics combination products"

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Regulatory Recon: New Global Pharma Head for GSK; Pharma CEOs Discuss Trump (20 January 2017) By Zachary Brennan - Published 20 January 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, NICE, Biologics and biotechnology, Combination products, Drugs, Human cell and tissue, Medical Devices

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

Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance By Zachary Brennan - Published 13 January 2017

The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device.

Categories: News, US, FDA, Clinical, Combination products, Compliance, Government affairs

Tags: Mylan, EpiPen, generic drug-device combination products, FDA draft guidance

FDA Offers Draft Guidance on New Pre-Request for Designation Process By Michael Mezher - Published 12 January 2017

After announcing a new program for sponsors to request earlier, informal input on combination product designations last August, the US Food and Drug Administration (FDA) has issued a new draft guidance detailing how to prepare such requests.

Categories: News, US, FDA, Combination products, Submission and registration

Tags: Pre-Request for Designation, Pre-RFD, Combination Products

FDA Offers Final Guidance on CGMP Requirements for Combo Products By Zachary Brennan - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday released final guidance describing and explaining the current good manufacturing practice (CGMP) requirements for combination products, first released in January 2013.

Categories: News, US, FDA, Combination products, Regulatory intelligence, Regulatory strategy

Tags: CGMP, combo products, FDA guidance

FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety By Zachary Brennan - Published 19 December 2016

More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products.

Categories: News, US, FDA, Combination products, Postmarket surveillance

Tags: combo product rule, FDA postmarket regulations, postmarket safety of combination products

Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA By Zachary Brennan - Published 28 November 2016

Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Government affairs, Human cell and tissue, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: 21st Century Cures, drug regulations, Congress and medical innovation, NIH, FDA innovation, Cures Now

Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics By Zachary Brennan - Published 18 October 2016

The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: companion diagnostics, IVDs, personalized medicine, Illumina, Genentech, AstraZeneca, BIO

NICE to Charge up to £282,000 for Each New Drug Assessment By Zachary Brennan - Published 03 October 2016

The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year.

Categories: News, Europe, EMA, NICE, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices

Tags: NICE assessment, NICE fees, EMA and HTA parallel assessment

Senators Question Mylan CEO Over EpiPen Pricing, Generic Plans By Michael Mezher - Published 31 August 2016

A group of 20 Senate democrats on Tuesday sent a letter to Mylan CEO Heather Bresch, questioning her about her company's actions in response to criticism over price increases for its life-saving EpiPen, which rose in price more than 400% over the past decade.

Categories: News, US, FDA, Combination products

Tags: Mylan, EpiPen

Senators to FDA: Where are the Alternatives to Mylan’s EpiPen? By Zachary Brennan - Published 25 August 2016

Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector.

Categories: News, US, FDA, Combination products, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: EpiPen, Mylan, Robert Califf, Grassley, Klobuchar, Ron Johnson

PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations By Zachary Brennan - Published 22 August 2016

Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the user fee program from fiscal years 2018 through 2022.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Manufacturing, Quality

Tags: AstraZeneca, PDUFA VI, PDUFA reauthorization, Prescription Drug User Fee Act

FDA Establishes New Process for Preliminary Combination Product Classification By Michael Mezher - Published 11 August 2016

Top officials at the US Food and Drug Administration (FDA) say the agency is developing a new, less formal, way for industry to request input on how combination products will be regulated.

Categories: News, US, FDA, Combination products

Tags: Combination products, Request for designation, RFD, Pre-RFD

FDA Begins Intercenter Pilot Project on Combination Products By Zachary Brennan - Published 01 August 2016

The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics.

Categories: News, US, FDA, Combination products, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: combo products, drug and device combination product, FDA pilot project

Advanced Therapies: Stakeholders Call for EMA Changes on Regulations, Manufacturing By Zachary Brennan - Published 03 June 2016

The European Medicines Agency (EMA) on Friday released a report outlining the concerns and regulatory changes described by developers, manufacturers and investors in advanced therapy medicinal products (ATMPs), which include gene therapies, tissue-engineered products and somatic cell therapies, at a meeting last week.

Categories: News, Europe, EC, Biologics and biotechnology, Blood, Clinical, Combination products, Crisis management, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: ATMPs, gene therapy manufacturing, cell therapy, advanced therapies

FDA Evaluating Risk of Burns and Scars With Migraine Patch By Zachary Brennan - Published 02 June 2016

Almost five years since the US Food and Drug Administration (FDA) rejected the approval of the Zecuity migraine patch because of burns (and then later approved a revamped version), the agency said Thursday it’s now investigating the battery-powered patch as “a large number of patients have reported they experienced burns or scars on the skin where the patch was worn.”

Categories: News, US, FDA, Combination products, Crisis management, Postmarket surveillance

Tags: Zecuity, migraine patch, drug patch burns, Teva Pharmaceuticals, NuPathe

FDA Official Dispels ‘100 Hours’ Myth on Time it Takes to Fill Out Compassionate Use Form By Zachary Brennan - Published 17 May 2016

The simplification of the US Food and Drug Administration’s (FDA) compassionate use process (announced last February and expected to be finalized very soon) may not actually be all that much of a simplification in terms of the amount of time it takes a physician to fill out the form, an FDA official told Focus on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Research and development

Tags: compassionate use, expanded access, Form 1571, Goldwater Institute, Form 3926

Expedited Compassionate Use for Investigational Drugs Coming Soon, FDA Says By Zachary Brennan - Published 16 May 2016

The fight over patients gaining access to investigational drugs via the compassionate use process is expected to get a lot easier in the near future, just as the US Food and Drug Administration’s (FDA) nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Crisis management, Drugs, Government affairs

Tags: compassionate use, Reagan-Udall Foundation, expanded access, right to try

Regulatory Recon: US Supreme Court Sends Obamacare Contraceptive Challenge to Lower Court; Pfizer Acquires Anacor for $5.2B (16 May 2016) By Zachary Brennan - Published 16 May 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, Oceania, US, CDSCO, EC, EMA, FDA, Health Canada, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Crisis management, Drugs, Government affairs, Labeling, Medical Devices, Postmarket surveillance, Quality

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

Regulatory Recon: Judge Backs Obamacare Challenge; White House Launches Microbiome Initiative (13 May 2016) By Zachary Brennan - Published 13 May 2016

Happy Friday the 13th! And welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. 

Categories: News, Africa, Asia, Europe, US, EC, EMA, FDA, Health Canada, WHO, Biologics and biotechnology, Combination products, Compliance, Crisis management, Drugs, Government affairs, Manufacturing, Medical Devices, Quality, Research and development

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

NIH’s Exclusive Licenses to Biotech, Pharma Start-Ups: Lots of Secrecy, Few Successes By Zachary Brennan - Published 10 May 2016

It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.

Categories: News, Asia, Europe, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, Research and development

Tags: NIH, exclusive start-up licenses, FDA inventions, FDA labs

Regulating Precision Medicine: Capacity vs. Overreach By Zachary Brennan - Published 05 May 2016

As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine.

Categories: News, Oceania, US, FDA, Biologics and biotechnology, Combination products, Drugs, Ethics, Government affairs

Tags: precision medicine, regulating DTC genomic tests, 23andMe

Three FDA Final Rules Slated for Release in May By Zachary Brennan - Published 04 May 2016

Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, Medical Devices

Tags: device trial data, combo product safety, pharmaceutical manufacturing facilities

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

FDA’s Nonprofit Arm Plots Out New Compassionate Use Navigator By Zachary Brennan - Published 07 April 2016

Patients and physicians desperate for access to a potentially life-saving investigational drug will be able to take some solace in the fact that the US Food and Drug Administration’s (FDA) nonprofit, known as the Reagan-Udall Foundation, is currently working on an online tool to help aid the process of obtaining what are known as "compassionate use" or "expanded access" treatments.

Categories: News, US, FDA, Blood, Clinical, Combination products, Crisis management, Drugs, Due Diligence, Government affairs, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: expanded access, Right to Try, compassionate use, Reagan-Udall Foundation

Senate Committee Advances Five More Bills as Part of Medical Innovation Package By Zachary Brennan - Published 06 April 2016

The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Combination products, Drugs, Due Diligence, Ethics, Government affairs, Labeling, Medical Devices, Packaging, Postmarket surveillance, Product withdrawl and retirement, Reimbursement

Tags: Senate companion bills to Cures, 21st Century Cures, Senate Medical Innovation, Senate HELP