Search Results for

Filtering on: "organizations agencies/organizations fda"

Showing 1 – 25  of 3918

Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance By Michael Mezher - Published 13 December 2017

The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections.

Categories: News, US, FDA, Drugs, In vitro diagnostics, Labeling

Tags: Antimicrobial Susceptibility Interpretive Test Criteria, Breakpoint, 21st Century Cures

Generic Drug Monthly Dashboard: FDA Adds New Metrics By Zachary Brennan - Published 13 December 2017

The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs.

Categories: News, US, FDA, Generic drugs

Tags: generic drug activity, GDUFA II

The Challenges and Strategies for Today's Rx-to-OTC Switch Programs By Julie Aker, MT(ASCP) - Published 13 December 2017

This article presents the background, approaches and regulatory considerations for prescription to Over-the-Counter (Rx-to-OTC) switch programs. The US Food and Drug Administration (FDA) has conservative expectations for the studies supporting a switch in terms of methodologies and sample sizes. Because of this, other countries will sometimes give consideration of consumer studies conducted in foreign countries on a case-by-case basis, in place of studies conducted in the local country.

Categories: Features, US, FDA, Over the counter drugs, Prescription drugs

Tags: OTC, OTC Switch

Resolving Gene Editing Technology's Ethical and Regulatory Challenges By Vidya Narayanaswami, PhD, Dr. Stephen F. Amato - Published 13 December 2017

This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges.

Categories: Features, FDA, Biologics and biotechnology, Ethics

Tags: Gene Editing, Gene Therapy, CRISPR, Cas9

Preparing for and Managing FDA Inspections By Sharry Arora, Bhaskar Saxena - Published 13 December 2017

The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish.

Categories: Features, US, FDA, Compliance, Drugs, Manufacturing

Tags: Inspections, GxP, Quality Management System, QMS, CAPA, CMC, Validation, Form 483, Quality Assurance

When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains By Zachary Brennan - Published 12 December 2017

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.

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

Tags: refuse to file, NDA, BLA, FDA draft guidance

CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures By Zachary Brennan - Published 12 December 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017.

Categories: News, CDRH, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance

Tags: patient-reported outcomes, medical device submissions

FDA Warns Korean OTC Drugmaker Using Noncompliant Contract Manufacturer By Zachary Brennan - Published 12 December 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Seoul, South Korea-based over-the-counter (OTC) drug manufacturer Seindni Co. for current good manufacturing practice (CGMP) violations and labeling concerns.

Categories: News, Asia, US, FDA, Over the counter drugs, Quality

Tags: Coko Loko, Legal Lean Syrup, Seindni

FDA Issues Draft Guidance on Gluten Labeling for Drugs By Michael Mezher - Published 12 December 2017

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance encouraging drugmakers to provide detailed labeling about whether their products are made from ingredients that contain gluten.

Categories: News, FDA, Drugs

Tags: Gluten, Gluten-Free, Labeling

Successful Human Factors Programs: Key Considerations from a Regulator's Perspective By Melissa R. Lemke - Published 12 December 2017

This article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market. It was developed from an interview with Shannon Hoste, team lead of the Center for Devices and Radiological Health's (CDRH's) human factors premarket evaluation team and Michael Ryan, acting deputy director in the division of anesthesiology, general hospital, respiratory, infection control, and dental devices.

Categories: Features, US, FDA, Medical Devices, Research and development

Tags: Human Factors Engineering, HFE, Guidance

FDA Finalizes Guidance on Promotional Drug Labeling and Ads By Zachary Brennan - Published 11 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: drug labeling, promotional and advertising guidance FDA, deceptive pharma ads

What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More By Zachary Brennan - Published 11 December 2017

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Research and development

Tags: CDRH guidance, 510(k) alternative pathway, PMA

Experts Look For Lessons in FDA's Pacemaker Cybersecurity Recall By Michael Mezher - Published 08 December 2017

In a paper in JAMA this week, two experts highlight lessons that could be learned from the US Food and Drug Administration's (FDA) first major cybersecurity-related recall for a permanent implantable medical device.

Categories: News, US, FDA, Communication, Medical Devices, Postmarket surveillance

Tags: Cybersecurity

Major vs. Minor ANDA Amendments: Industry Takes Issue With FDA Draft Guidance By Zachary Brennan - Published 08 December 2017

The generic drug industry association, Teva Pharmaceuticals and Sanofi have raised questions in comments released this week on the US Food and Drug Administration’s (FDA) recent draft guidance on abbreviated new drug application (ANDA) amendments.

Categories: News, US, FDA, Generic drugs

Tags: ANDA amendments, FDA draft guidance

Have PRVs Incentivized New Rare or Neglected Disease Research? Experts Discuss By Zachary Brennan - Published 08 December 2017

The priority review voucher (PRV) programs, created by Congress with an eye to incentivizing the development of new rare pediatric and neglected tropical disease drugs, have so far rewarded a wide range of small and large biopharma companies and projects, though whether PRVs have actually spurred new research remains a question.

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

Tags: priority review voucher, neglected tropical disease, rare pediatric disease

Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted By Zachary Brennan - Published 07 December 2017

The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies.

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

Tags: post-approval studies, research requirements, post-marketing research

FDA Backs Off From Regulating Certain Types of Health Software By Zachary Brennan - Published 07 December 2017

The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated.

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

Tags: digital health, health software, 21st Century Cures

FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts By Zachary Brennan - Published 06 December 2017

The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C.

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

Tags: opioids, FDA enforcement, FDA compliance, FDLI, stem cells

More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance By Zachary Brennan - Published 06 December 2017

The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could speed the development of treatments for rare pediatric disease drugs.

Categories: News, US, EMA, FDA, Clinical, Drugs

Tags: rare pediatric disease, Gaucher, FDA draft guidance

FDA's Frey Reflects on Final Year of PDUFA V By Michael Mezher - Published 06 December 2017

As the year comes to a close, Patrick Frey, senior advisor to the director of the Office of New Drugs (OND) at the Center for Drug Evaluation and Research (CDER), looked back at FDA's performance over the final year of the fifth iteration of the Prescription Drug User Fee Act (PDUFA V) and what's to come in PDUFA VI.

Categories: News, US, CDER, Biologics and biotechnology, Communication, Drugs, Orphan products, Submission and registration

Tags: PDUFA, NDA, BLA, Orphan Drugs, Approvals

FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities By Zachary Brennan - Published 06 December 2017

The US Food and Drug Administration’s (FDA) Toxicology Working Group this week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing.

Categories: News, US, FDA, Drugs, Preclinical, Regulatory intelligence

Tags: toxicology, FDA toxicology working group

FDA Warns California Device Company for Failing to Disclose Serious Injury By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.

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

Tags: warning letter, device injury

Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds By Zachary Brennan - Published 05 December 2017

Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ.

Categories: News, US, FDA, Clinical, Research and development

Tags: clinical trial transparency, Johnson & Johnson, Sanofi, Valeant, Allergan

Woodcock: CDER Informatics System is Top Priority for 2018 By Michael Mezher - Published 05 December 2017

Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Generic drugs, Over the counter drugs, Prescription drugs, Submission and registration

Tags: 21st Century Cures, Informatics, CDER

NEST Seeks Medical Device Test Cases for Using Real World Evidence By Zachary Brennan - Published 05 December 2017

The National Evaluation System for health Technology Coordinating Center (NESTcc) this week put out three requests for proposals to help it build the case for using real world evidence for regulatory and coverage decisions for medical devices.

Categories: News, US, FDA, Clinical, In vitro diagnostics, Medical Devices, Postmarket surveillance, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: NEST, NESTcc, real world data, real world evidence