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Filtering on: "topics communication"

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Priority Generic Drug Reviews: New FDA Draft Guidance By Michael Mezher - Published 19 June 2017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the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.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

New Study Says 63% of US Adults Trust FDA By Zachary Brennan - Published 17 May 2017

A study published Tuesday in PLOS reveals that the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) might have more work to do to ensure Americans trust them.

Categories: News, US, FDA, Business and Leadership, Communication, Drugs, Government affairs

Tags: FDA public opinion, CDC

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

The Relationship Between Regulatory and Commercial Organizations: How to Work With Your Commercial Colleagues By Mary Ellen Cosenza, PhD, RAC - Published 16 March 2017

This article discusses why regulatory and business functions need to work together to ensure success in label development, launch, promotion and lifecycle management strategy and regulatory intelligence and provides successful partnership examples.

Categories: Features, Business Skills, Communication

FDA Finalizes Postmarket Cybersecurity Guidance By Michael Mezher - Published 03 January 2017

Just before the close of 2016, the US Food and Drug Administration (FDA) finalized its guidance for managing postmarket cybersecurity for connected medical devices.

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

Tags: Cybersecurity, Medical Device Cybersecurity

Automation Best Practices for Managing Regulatory Processes: Part 2 By James Reilly - Published 23 November 2016

This article shares observations from regulatory experts on how to compliantly and efficiently manage change events, such as label or manufacturing changes, with health authorities globally.

Categories: News, Communication

Why Respond to an FDA 483 in a Timely Manner By Alan Minsk, Kelley Nduom - Published 21 November 2016

We reviewed some warning letters issued by the US Food and Drug Administration (FDA) this year that reminded us of the 1981 hit song by Styx, "Too Much Time on My Hands." Two companies had received a FDA 483 List of Observations following an inspection.1, 2 The companies accordingly responded to the agency within 15 business days; however, they also provided subsequent substantive responses to the FDA 483 outside of the 15-day window. In the warning letters, FDA acknowledged the companies' initial responses, but noted the subsequent responses were untimely and not reviewed by the agency as it considered potential next enforcement steps.

Categories: Features, US, FDA, Communication, Compliance, Regulatory strategy

GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders By Michael Mezher - Published 18 November 2016

A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain.

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

Tags: Drug Compounding, Outsourcing Facility, Government Accountability Office, GAO

Recent Trends in Prescription Drug Promotion Enforcement By Francis Nguyen, Colin Vechery - Published 17 November 2016

This article presents brief summaries of the 2016 enforcement letters, analyzes how different data cuts, groupings and correlations to relatable events can be constructed to explain different trends and introduces some key events along the enforcement letter timeline.

Categories: Features, US, FDA, Advertising and Promotion, Communication

Using Twitter as an Intelligence Tool: 85 Accounts Worth Following By Zachary Brennan - Published 16 November 2016

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical device spaces, for investors, and even for the regulators themselves, Twitter is a great place to catch the day’s breaking news before the headlines are written.

Categories: News, Asia, Europe, US, Advertising and Promotion, Biologics and biotechnology, Business and Leadership, Communication, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Twitter, regulatory affairs, regulatory intelligence

FDA Questions Need for Looser Off-Label Promotion Restrictions By Michael Mezher - Published 14 November 2016

Officials from the US Food and Drug Administration (FDA) last week questioned industry arguments for looser regulations on off-label promotion for drugs and devices at a two-day public hearing at FDA's White Oak campus.

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

Tags: Off-label promotion

RAPS Regulatory Convergence - 2016 Hot Topic Review By Sara Bobbit - Published 09 November 2016

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions covering innovation and technology, Zika, real world evidence, patient access to innovative medicines and recent developments in off-label promotion.

Categories: News, Japan, Europe, US, FDA, MHLW, PMDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Drugs, Labeling, Medical Devices, Research and development, Submission and registration

Tags: Regulatory Convergence, 2016 RAPS

Drug Marketing on Twitter: FDA to Study Space-Limited Communications By Michael Mezher - Published 07 November 2016

The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: Social media, Twitter, Google

Off-Label Promotion: Researchers Call on Courts to Reject Caronia By Michael Mezher - Published 03 November 2016

Two researchers are calling for the US Food and Drug Administration (FDA) to take a stand against off-label promotion in light of recent legal proceedings, and urge the courts to reject the precedent set in United States v. Caronia.

Categories: News, US, FDA, Advertising and Promotion, Communication, Drugs, Medical Devices

Tags: Caronia, Amarin, Pacira, Aaron Kesselheim, Christopher Robertson, Off-label promotion

FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective By Alan Minsk, Kelley Nduom - Published 20 October 2016

Despite all of the public discussion about FDA's enforcement approach in the off-label promotional arena, the agency continues to take action against any perceived unlawful promotion. Recently, FDA issued Notice of Violation letters to drug companies for promoting their investigational new drugs as safe and effective.

Categories: Features, US, FDA, Advertising and Promotion, Communication, Drugs

Tags: Notice of Violation

Standardization Best Practices for Managing Regulatory Processes: Part 1 By James Reilly - Published 11 October 2016

This article reviews the most common standardization challenges, including inconsistent data definition, data capture and processes and suggests system consolidation and automation will only succeed if data is standardized and processes are harmonized.

Categories: Features, Communication, Regulatory strategy

Tags: Standardization, Data Capture, Processes

Changing Times of Advertising and Promotion, Hot Topics and a Preview of October By Gloria Hall - Published 06 October 2016

The following is a summary of feature articles posted throughout September with links and a preview of what's to come in October.

Categories: Features, Advertising and Promotion, Communication

Do Recent First Amendment Court Developments Deal a Blow to the Government? By Alan Minsk, Kelley Nduom - Published 05 October 2016

This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications.

Categories: Features, US, FDA, Advertising and Promotion, Communication, Drugs, Government affairs

Tags: Amarin, Pacira, Vascular Solutions, First Amendment, Off-label promotion

RAPS and the Regulatory Profession: Two-Way Communication Between Industry and Regulators By Mary Meahger - Published 22 August 2016

When the regulatory profession convenes for the 2016 Regulatory Convergence in San Jose next month, it will be an occasion for members from both government and industry to build on their working relationships, to discuss with one another new guidelines and compliance issues and, generally, to bridge their understanding about regulatory matters unique to those who work in different facets of the profession.

Categories: HTML, Articles, Under RAPS, About the Profession, Communication

Tags: RAPS 40th Anniversary, regulatory profession, communication

10 Disruptive Technologies and the Regulatory Implications By Zachary Brousseau - Published 17 August 2016

The healthcare products sector has seen the introduction and development of a number of disruptive technologies in recent years. The future of healthcare lies in groundbreaking tech like 3D printing and personalized medicine. But these new innovations also bring regulatory challenges. This article examines 10 disruptive technologies regulatory professionals should be tracking.

Categories: HTML, Articles, Under RAPS, RAPS, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Compliance, Ethics, Labeling, Manufacturing, Medical Devices, Packaging

Tags: disruptive technology, regulation, Regulatory Convergence, #2016RAPS

Health Canada to Develop Better Risk Communications on Essure Contraceptive Devices By Michael Mezher - Published 25 May 2016

Canadian drug and device regulator Health Canada on Monday said it is working with Bayer to develop better risk communication for the permanent birth control device Essure after a safety review of the device found the its risks are not adequately communicated.

Categories: News, Canada, FDA, Health Canada, Communication, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer

Using Social Media to Promote FDA-Regulated Products - A Balanced Approach is Best By Elizabeth Heredia - Published 22 April 2016

This article shares some of the current thinking on best practice uses of social media in promoting FDA-regulated products.

Categories: Features, FDA, Advertising and Promotion, Communication, Drugs

Tags: Social media

Meeting With EU Regulatory Agencies: Part II By Delphine Kazancigil, Marie Deneux, Marie Deneux - Published 06 April 2016

This article discusses the main types of European regulatory agency interactions an applicant may have during the development of a medicinal product in the EU, on the path to registration. It provides the rationale to request meetings with European authorities and presents the procedures and protocols involved with these interactions.

Categories: Features, Europe, EMA, MHRA, Communication, Regulatory strategy

Cybersecurity Researcher: Recent Device Vulnerabilities Should Be a Wake-Up Call for FDA By Michael Mezher - Published 05 April 2016

A prominent cybersecurity researcher says the US Food and Drug Administration (FDA) needs to "buckle down" and regulate medical device cybersecurity more firmly.

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

Tags: Cybersecurity, ICS-CERT, Pyxis SupplyStation, Mike Ahmadi, Billy Rios

Meeting With EU Regulatory Agencies: Part I By Delphine Kazancigil, Marie Deneux, Frederic Loussala - Published 28 March 2016

This article discusses the main types of European regulatory agency meetings and interactions an applicant may have during the development of a medicinal product on the path to registration in the EU. It provides some insight on the rationale to request meetings with European authorities and procedures and protocols involved with these meetings.

Categories: Features, Europe, EMA, MHRA, Biologics and biotechnology, Communication, Drugs, Submission and registration