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Filtering on: "organizations agencies/organizations fda"

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Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration By Zachary Brennan - Published 28 March 2017

With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion.

Categories: News, Asia, Canada, Europe, US, APEC, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical supply chain, good manufacturing practices, good distribution practices, fake drugs

FDA Warns Singapore Ophthalmic Drug Manufacturing Site By Zachary Brennan - Published 28 March 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 16 March to Singapore-based Opto-Pharm for its failure to address leaking containers and bottle defects, among other violations.

Categories: News, US, FDA, Drugs, Manufacturing, Regulatory strategy

Tags: sterile eye wash, FDA warning letters

FDA Office of Regulatory Affairs Realignment to Begin in May By Michael Mezher - Published 28 March 2017

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Categories: News, US, FDA, Compliance, Medical Devices

Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce

Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations By Zachary Brennan - Published 27 March 2017

The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Research and development

Tags: diagnostics, IVDs, IVCT, in vitro clinical test, LDT, lab-developed test

CDRH Seeks Participants for Staff Training Program By Zachary Brennan - Published 24 March 2017

Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices. 

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

Tags: ELP, CDRH training, staff training FDA devices

FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients By Michael Mezher - Published 23 March 2017

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients.

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

Tags: Delayed Graft Function, DGF, Draft Guidance

Fast Facts: Serious Adverse Event Reporting Requirements in the US By Valerie Fauvelle, MS, RAC - Published 22 March 2017

This article presents reporting requirements for Serious Adverse Events (SAEs) and focuses on an important, but often overlooked regulation that specifies when a study is being run and includes the use of an approved drug. There are reporting requirements with specific timeframes that must be followed if there is a reportable SAE attributed to the approved drug.

Categories: Features, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: Adverse Event Reporting

Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire By Michael Mezher - Published 22 March 2017

Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI).

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

Tags: PDUFA VI, Prescription Drug User Fee Act

When to Submit a 510(k) (Devices and Software): A Regulatory Perspective By Jeff Ryberg - Published 21 March 2017

This article explores key elements of the US Food and Drug Administration's (FDA's) latest draft guidance to industry for deciding when to submit a new 510(k) for medical device hardware and software design changes. The potential business impact is assessed and suggestions are provided for what companies need to do to align with FDA's current thinking.

Categories: Features, US, FDA, Medical Devices, Submission and registration

Tags: 510(k), Software

FDA Warns Two Drugmakers in China and India for Data Integrity Violations By Michael Mezher - Published 21 March 2017

The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year.

Categories: News, China, India, US, FDA, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity

FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants By Zachary Brennan - Published 21 March 2017

The US Food and Drug Administration (FDA) on Tuesday said it now concurs with the World Health Organization’s designation of an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma.

Categories: News, US, FDA, TGA, WHO, Compliance, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: breast implants, lymphoma, BIA-ALCL

CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee By Zachary Brennan - Published 21 March 2017

The US Senate Health, Education, Labor & Pensions Committee on Tuesday pressed three top US Food and Drug Administration (FDA) officials for details on how plans to reauthorize their user fee programs would help to further streamline medical product approvals.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: FDA user fees, GDUFA, BsUFA, MDUFA, PDUFA, Senate HELP

FDA Approved Nearly All Expanded Access Requests in FY2016 By Michael Mezher - Published 20 March 2017

The US Food and Drug Administration (FDA) granted more than 99% of requests for patients to access unapproved drugs and biologics in fiscal year 2016, according to data released last week.

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

Tags: Expanded Access, Compassionate Use, Right-To-Try

Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky' By Zachary Brennan - Published 20 March 2017

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

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

Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports

Humacyte Receives First of FDA’s Regenerative Medicine Designations By Zachary Brennan - Published 20 March 2017

The US Food and Drug Administration (FDA) on Monday offered one of its first Regenerative Medicine Advanced Therapy (RMAT) designations to Humacyte’s investigational human acellular vessel (HAV) Humacyl.

Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: RMAT designation, regenerative medicine, 21st Century Cures

FDA Offers 2016 Report on Medical Countermeasure Activities By Zachary Brennan - Published 20 March 2017

As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Quality

Tags: medical countermeasures, Ebola, Zika, flu vaccine

Bills Introduced in March: Importation, Cancer Drugs and PBM Transparency By Zachary Brennan - Published 17 March 2017

At least nine US House and Senate bills introduced in March would impact the pharmaceutical industry, including three to allow for more prescription drug imports from Canada, pharmacy benefit management (PBM) transparency and one on cost sharing for cancer medicines.

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

Tags: Cummings, Sanders, drug prices, PBMs

FDA Delays Final Rule on Intended Uses By Michael Mezher - Published 17 March 2017

The US Food and Drug Administration (FDA) on Friday announced it will delay implementation of its final rule clarifying when tobacco products are regulated as medical products until March 2018 in response to a petition from biopharmaceutical industry groups that raised questions about how the rule would alter the agency's definition of intended uses for drugs and medical devices.

Categories: News, US, FDA, Biologics and biotechnology, Communication, Drugs, Medical Devices

Tags: Intended Use, Final Rule, Totality of Evidence

Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.

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

Tags: GlaxoSmithKline, Regeneron, Novartis, Teva, BIO, Celgene, AstraZeneca, clinical trial endpoints

Trump FY 2018 Budget Blueprint: Hike in FDA User Fees? By Zachary Brennan - Published 16 March 2017

President Donald Trump’s administration released its budget blueprint for FY 2018 on Thursday, calling for a hike in user fees from industry to make up for cuts elsewhere at the US Food and Drug Administration (FDA).

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Trump budget, FDA budget 2018, user fees, user fee reauthorization

FDA Transparency: Agency’s Hands Tied by its own Regulations By Zachary Brennan - Published 15 March 2017

Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: FDA transparency, CRLs, biosimilars

BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics By Michael Mezher - Published 15 March 2017

The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Packaging

Tags: Mixing, Diluting, Repackaging, Compounding, Outsourcing Facilities, BIO, Pew

FDA Warns of Increased Risk of Serious Pancreatitis with Allergan’s Viberzi By Zachary Brennan - Published 15 March 2017

Following the death of two patients without a gallbladder on Allergan’s irritable bowel drug Viberzi (eluxadoline), the US Food and Drug Administration (FDA) on Wednesday warned about the increased risk of serious pancreatitis in such patients.

Categories: News, US, FDA, Crisis management, Drugs, Postmarket surveillance

Tags: Viberzi, pancreatitis, Viberzi deaths, gallbladder

House Committee Asks FDA for More Info on Contaminated Heparin Investigations By Zachary Brennan - Published 15 March 2017

Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, China heparin, House E&C, FDA investigations

New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India By Zachary Brennan - Published 14 March 2017

The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs

Tags: warning letters, API manufacturers, water and pharmaceuticals