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AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process By Zachary Brennan - Published 27 June 2017

Does a medical device cleared under the US Food and Drug Administration's 510(k) review process mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.

Categories: News, US, FDA, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: SCOTUS, Supreme Court, AdvaMed, 510(k)

FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition By Zachary Brennan - Published 27 June 2017

The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug.

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

Tags: generic drugs, priority review of generics, drug price competition, drug prices

GAO: FDA Needs a Plan for GDUFA Carryover Fees By Michael Mezher - Published 27 June 2017

As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: GDUFA, User Fees, Carryover, Government Accountability Office, GAO

House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017 By Zachary Brennan - Published 27 June 2017

The House Appropriations Committee on Tuesday released the fiscal year 2018 Agriculture Appropriations bill, which would enact a total of $2.8 billion in discretionary funding for the US Food and Drug Administration.

Categories: News, US, FDA, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: FDA FY 2018, FDA budget, FDA appropriations

Biological Products and Biosimilars: Global Naming Debate By Pallavi Trivedi - Published 27 June 2017

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN

Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse By Michael Mezher - Published 26 June 2017

In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: REMS, Generic Competition

FDA, NCI to Collaborate Further on Cancer Research By Zachary Brennan - Published 26 June 2017

The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment.

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

Tags: National Cancer Institute, proteogenomics, cancer research

Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations By Zachary Brennan - Published 26 June 2017

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology.

Categories: News, US, FDA, Clinical, Drugs, Medical Devices

Tags: CTTI, mobile technology and clinical trials, novel trial endpoints

FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years By Zachary Brennan - Published 26 June 2017

The launch of the US biosimilars market has been slow since the pathway for approvals was set up in 2010, with only five US Food and Drug Administration (FDA) biosimilar approvals, none of which have been approved as interchangeable biosimilars.

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

Tags: biosimilars, interchangeable biosimilars, interchangeability, biosimilar substitution

Regulating CRISPR: FDA and Industry Offer Perspective By Zachary Brennan - Published 21 June 2017

Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: CRISPR-Cas9, CRISPR regulation, FDA and CRISPR, Editas, Intellia, CRISPR Therapeutics

FDA Warns Chinese API Maker for Data Integrity Issues By Michael Mezher - Published 21 June 2017

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: Data Integrity

Gottlieb Looks to Boost Generic Drug Competition By Michael Mezher - Published 21 June 2017

As the US continues to grapple with the high cost of prescription drugs, the Food and Drug Administration (FDA) on Wednesday announced plans to stop drugmakers from gaming the system to block generic competition.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: REMS, Competition, Generic Drugs

FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests By Michael Mezher - Published 20 June 2017

At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments.

Categories: News, US, FDA, Generic drugs, Orphan products

Tags: FY2018 Budget, Appropriations, Orphan Drug Designations, REMS, Scott Gottlieb

CBER Director Offers a Peek Into the Complexities of Where the Center is Headed By Zachary Brennan - Published 20 June 2017

In addition to protecting the US blood supply and ensuring vaccines are safe and effective, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is also now regulating complex gene and cell therapies, as well as a new category of treatments: regenerative medicines.

Categories: News, US, CBER, Biologics and biotechnology

Tags: CBER, CAR-T, hemophilia, Peter Marks

FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations By Michael Mezher - Published 20 June 2017

The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations.

Categories: News, US, FDA, Clinical

Tags: Electronic systems, Mobile technology

Priority Generic Drug Reviews: New FDA Draft Guidance By Michael Mezher - Published 19 June 2017

In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.

Categories: News, US, FDA, Communication, Generic drugs, Submission and registration

Tags: Priority Generics, ANDA, Pre-Submission Facility Correspondence, PFC

US FDA Sees Major Spike in BA/BE Studies in India By Zachary Brennan - Published 19 June 2017

In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.

Categories: News, India, US, CDSCO, FDA, Clinical, Crisis management, Generic drugs, Government affairs

Tags: BA and BE studies, bioequivalence, generic drugs from India

CBO Releases Cost Estimate for User Fee Bill By Michael Mezher - Published 19 June 2017

The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Prescription drugs, Government affairs, Medical Devices, Submission and registration

Tags: CBO, User Fees, Reauthorization

FDA Offers Updated Form for Field Alert Reports By Michael Mezher - Published 16 June 2017

The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program.

Categories: News, US, FDA, Generic drugs, Prescription drugs, Postmarket surveillance

Tags: FAR, Field Alert Reports

Trump Administration Officials Huddle at White House to Discuss Drug Pricing By Zachary Brennan - Published 16 June 2017

A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients."

Categories: News, US, FDA, Drugs

Tags: Trump, drug pricing, White House meeting on drug prices

FDA Extends Use Dates for Pfizer Injectables to Ease Shortage By Michael Mezher - Published 16 June 2017

The US Food and Drug Administration (FDA) on Thursday said it is extending the use dates of multiple lots of injectable drugs made by Pfizer subsidiary Hospira by six months to a year in response to an ongoing shortage of the drugs.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing

Tags: Pfizer, Hospira, Shortage

FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review By Zachary Brennan - Published 15 June 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

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

Tags: digital health, FDA digital health, software as a medical device

Caribbean Regulatory System Begins Recommending Generic Drugs By Zachary Brennan - Published 14 June 2017

The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments.

Categories: News, Latin America and Caribbean, FDA, WHO, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Caribbean medicines, Caribbean drug regulators, WHO, PAHO, Caribbean Regulatory System

FDA Used Real-World Evidence in Heart Valve Approval By Michael Mezher - Published 14 June 2017

The US Food and Drug Administration (FDA) says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement (TAVR) to valve-in-valve procedures.

Categories: News, US, CDRH, Medical Devices, Submission and registration

Tags: Sapien 3, Edwards Lifesciences, Real-World Evidence

FDA Offers Biomarker Qualification Case Studies By Zachary Brennan - Published 14 June 2017

As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.

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

Tags: biomarker qualification, FDA case studies, biomarkers, drug development