Search Results for Zachary Brennan

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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

Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees By Zachary Brennan - Published 20 January 2017

Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Rob Califf, FDA commissioner, benefit-risk assessments, pharmaceuticals, medical devices

FDA Begins Accepting Regenerative Therapy Applications for RAT Designation By Zachary Brennan - Published 20 January 2017

The US Food and Drug Administration (FDA) on Thursday unveiled a new designation category created as part of the 21st Century Cures Act making drugs eligible for designation as a regenerative advanced therapy (RAT).

Categories: News, US, CBER, Biologics and biotechnology, Drugs, Human cell and tissue

Tags: RAT designation, regenerative therapy, cell therapy, OTAT

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

Politicizing the FDA: What the Trump Win Means for New Pharma Regulations By Zachary Brennan - Published 19 January 2017

President-Elect Donald Trump on Friday will become the 45th US president and though he’s yet to name his choice for commissioner of the US Food and Drug Administration (FDA), the names of those floated to lead the agency and a recent flood of new draft and finalized FDA guidance reveal an agency bracing for change.

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

Tags: Trump, FDA, FDA commissioner pick, Rob Califf

FDA Form 483 Cites 14 Observations for Zimmer Biomet By Zachary Brennan - Published 19 January 2017

Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Warsaw, IN-based site with 14 observations.

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

Tags: Zimmer Biomet, Form 483, CAPA

Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications By Zachary Brennan - Published 18 January 2017

When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public, be considered in violation of the law or US Food and Drug Administration (FDA) regulations?

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Labeling, Regulatory intelligence, Regulatory strategy

Tags: off-label drug communications, off-label marketing, First Amendment and pharmaceuticals, FDA guidance

Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown By Zachary Brennan - Published 18 January 2017

A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety.

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

Tags: foreign pharmaceutical inspections, FDA foreign offices, FDA in China, FDA and India

FDA’s Approval of Generic Version of Jazz Pharma’s Sleep Disorder Drug Raises Questions By Zachary Brennan - Published 18 January 2017

The US Food and Drug Administration (FDA) late Tuesday approved a generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) to help treat a sleep disorder but at least one investment analyst thinks the move could lead to a slippery slope of companies adding drug-drug interaction (DDI) patents and using them to keep generics from entering the market.

Categories: News, US, FDA, Generic drugs, Labeling

Tags: Jazz Pharmaceuticals, Xyrem, generic approvals

FDA Finalizes Guidance on Assessing Abuse Potential of Drugs By Zachary Brennan - Published 18 January 2017

A guidance finalized on Wednesday, almost six years after it was first drafted, looks to help sponsors of investigational new drugs in evaluating whether their new drug product has abuse potential.

Categories: News, US, FDA, Drugs

Tags: Abuse Potential, Prescription Drug Abuse, Guidance

NICE Halts Plans to Charge for Appraisals By Zachary Brennan - Published 16 January 2017

The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Reimbursement

Tags: Brexit, UK Life Sciences, ABPI, NICE

Drug Compounding With Bulk Substances: FDA Offers Interim Policies By Zachary Brennan - Published 16 January 2017

The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Quality

Tags: drug compounding, compounded drugs, 503A, 503B, FDA interim policy

EMA Reveals List of Eligible Industry Stakeholder Organizations By Zachary Brennan - Published 16 January 2017

The European Medicines Agency (EMA) on Monday disclosed a new list of eligible industry stakeholder organizations that can consult and cooperate with the agency in specific areas.

Categories: News, Europe, EC, EMA, Business and Leadership, Government affairs

Tags: drug industry stakeholders

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

US Supreme Court to Review Biosimilar ‘Patent Dance’ By Zachary Brennan - Published 13 January 2017

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Due Diligence, Government affairs

Tags: SCOTUS, John Roberts, biosimilar patent dance, biosimilars and SCOTUS

FDA Draft Guidance Looks to Help Speed New Generics to Market By Zachary Brennan - Published 13 January 2017

The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals.

Categories: News, FDA, Generic drugs, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy

Tags: RLD, generic drugs, ANDA, ANDA submission

FDA Further Explains Delay on LDT Guidance By Zachary Brennan - Published 13 January 2017

Two months after saying it would not finalize guidance on the regulation of lab-developed tests (LDTs), the US Food and Drug Administration (FDA) on Friday published a discussion paper with some hints as to how it would like the discussion and regulations on this thorny issue to move forward.

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

Tags: lab-developed tests, LDTs, FDA on lab tests

Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance By Zachary Brennan - Published 12 January 2017

In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

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

Tags: biosimilar names, non-proprietary biologic naming, biologic names, FDA guidance

Multiple Endpoints in Clinical Trials: FDA Issues Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry on the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: endpoints, clinical trials, clinical guidance, FDA guidance

ICH Offers Reflection Paper on Good Clinical Practice Revisions By Zachary Brennan - Published 12 January 2017

The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct.

Categories: News, Asia, Canada, US, ICH, Clinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: Good Clinical Practice, ICH guidance, ICH E6, ICH E8

180-Day Exclusivity for Generics: FDA Releases Draft Guidance By Zachary Brennan - Published 12 January 2017

The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs.

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

Tags: 180-day exclusivity, generic drugs, FDA guidance

FDA and MHRA Break Down Foreign Inspection Data By Zachary Brennan - Published 11 January 2017

Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics.

Categories: News, Europe, US, FDA, MHRA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: foreign drug inspections, foreign device inspections

CDER Guidance in 2017: Lots of Procedural and Quality Documents Coming By Zachary Brennan - Published 11 January 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released its agenda of new and revised draft guidance documents to be published this calendar year, and it includes several eagerly-awaited documents, such as ones on biosimilar interchangeability (which has been on the list since 2015) and a revision of a draft on postmarket safety reporting for drugs and biologics.

Categories: News, US, CDER, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: interchangeability, FDA guidance, guidance agenda, CDER guidance

Trump Sides With HHS’ Burwell and Democrats on Drug Price Negotiations By Zachary Brennan - Published 11 January 2017

President-elect Donald Trump on Wednesday opened his press conference with an unexpected shot at pharmaceutical companies and their lobbying groups on Capitol Hill, saying, "They’re getting away with murder."

Categories: News, US, Drugs, Government affairs

Tags: Donald Trump, PEOTUS, Burwell, Medicare Part D, drug price negotiations

FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances By Zachary Brennan - Published 10 January 2017

The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances.

Categories: News, US, FDA, WHO, Drugs, Government affairs, Product withdrawl and retirement

Tags: cannabis, marijuana, controlled substances, DEA