Search Results for regulation

Showing 1 – 25  of 143

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

Application of EU Clinical Trial Regulation Delayed to 2019 By Zachary Brennan - Published 16 June 2017

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

Categories: News, Europe, EC, EMA, Clinical, Compliance, Government affairs

Tags: EMA clinical trial regulation, clinical trial regs, EMA portal

6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation By Paul Brooks - Published 15 June 2017

When the EU’s new Medical Devices Regulation (MDR) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready.

Categories: Europe, EC, Medical Devices

Tags: Europe MDR, medical device regulation, new device regulations in Europe

Australia Considers Allowing the Marketing of Devices Approved Overseas By Zachary Brennan - Published 22 May 2017

Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled a plan to further converge its medical device regulations with those from comparable overseas regulators and allow for the use of devices that have received marketing approvals from some foreign authorities.

Categories: News, Oceania, TGA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Australia's TGA, medical devices in Australia, conformity assessments, regulation of devices

FDA Officials Discuss Modernizing the Regulation of Combo Products By Zachary Brennan - Published 15 May 2017

As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature.

Categories: News, US, FDA, Combination products, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: combination product regulation, combo products and FDA, 21st Century Cures

Impact of the Revised EU Clinical Trial Regulation By Siegfried Schmitt, Federico Bonacci, MD, Daniela Lisini, PhD, Dr. Viviana Mascilongo - Published 24 April 2017

Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.

Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs

Tags: Clinical Trial Regulation, EU No 536/2014

GAO Survey of State Regulation of Drug Compounding Offers Mixed Results By Zachary Brennan - Published 31 March 2017

Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use.

Categories: News, US, FDA, Drugs

Tags: GAO, drug compounding, regulation of drug compounders

MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU By Rod Ruston - Published 03 March 2017

This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Medical Device Regulation, In Vitro Diagnostic Medical Devices Regulation, MDR, IVDR

ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success By Michael Mezher - Published 26 January 2017

France's Agency Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on Wednesday reported positive results for its year-long pilot for assessing clinical trials using the process established in the new EU Clinical Trials Regulation.

Categories: News, Europe, Clinical

Tags: ANSM, Clinical Trials Regulation

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs

European Commission Clears up Questions on Orphan Drug Regulation By Michael Mezher - Published 05 January 2017

Following a public consultation in November 2015, the European Commission (EC) has released a new communication intended to clarify some lingering questions about the EU's Orphan Regulation.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Orphan products

Tags: Orphan Regulation, Orphan Drugs, Orphan Designation

EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report By Zachary Brennan - Published 15 November 2016

The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the Pediatric Regulation, ten years after its implementation.

Categories: News, Europe, EC, EMA, MHRA, Clinical, Compliance, Due Diligence, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Paediatric Regulation, PIPs, PIP cost to pharmaceutical industry

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

FDA Warns 14 International Medical Device Companies By Michael Mezher - Published 16 August 2016

The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines.

Categories: News, China, Europe, Latin America and Caribbean, US, CDRH, Medical Devices

Tags: Quality System Regulation, Medical Device Reporting, Corrective and Preventative Action, CAPA, Warning Letter

FDA Declares ‘General Wellness’ Devices Exempt From Regulations By Michael Mezher - Published 28 July 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements.

Categories: News, US, FDA, Government affairs, Medical Devices, Postmarket surveillance, Submission and registration

Tags: medical device regulation, health apps, mobile medical apps, mhealth, exercise equipment and FDA

EC Report Analyzes Regulatory Frameworks for Advanced Therapies in US, Canada, Japan and Korea By Zachary Brennan - Published 06 July 2016

The European Commission report released Wednesday dissects the similarities in how gene-, cell- and tissue-based advanced therapies are regulated across the four different geographic regions, though ongoing research projects in such therapies are heavily concentrated in the US and Japan.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, Health Canada, MHLW, PMDA, Biologics and biotechnology, Clinical, Government affairs, Human cell and tissue

Tags: advanced therapies, gene therapies, reports on advanced therapies, gene therapy regulation

Brexit Conundrum: How Does MHRA Work With EMA Moving Forward By Zachary Brennan - Published 24 June 2016

With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices, Postmarket surveillance

Tags: Brexit, UK regulation of medicines, regulation of drugs after Brexit

Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads By Zachary Brennan - Published 04 May 2016

Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements.

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

Tags: pharma ads, efficacy claims in pharmaceutical advertising, FDA regulation of pharma ads

European Parliament Looks to Take Over EMA Fee Process By Zachary Brennan - Published 11 April 2016

The European Parliament has voted to lessen the European Commission’s control of the structure and level of fees charged by the European Medicines Agency (EMA), which may instead be set by members of Parliament and European Union (EU) ministers.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Parliament, EU Council, European Commission, EMA fees, EMA regulation

FDA Collaborates With FTC on Mobile Health App Regulatory Tool By Zachary Brennan - Published 05 April 2016

The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws.

Categories: News, US, FDA, FTC, Business Skills, Compliance, Government affairs, Medical Devices

Tags: mHealth regulation, mobile health apps, health applications

India's Supreme Court Denies Petitions Challenging CDSCO By Zachary Brennan - Published 11 March 2016

Dinesh Thakur, the now-famous Ranbaxy whistleblower who won more than $48 million for calling out the company’s drug safety issues to the US Department of Justice, failed on Friday to get the Supreme Court of India to take up two petitions seeking to challenge the law under which India’s drug regulator Central Drugs Standard Control Organization (CDSCO) operates.

Tags: Supreme Court of India, Dinesh Thakur, CDSCO, India drug regulation

Regulators, Industry Weigh in on Proposed EU Orphan Regulation Changes By Zachary Brennan - Published 07 March 2016

As the number of orphan drug approvals continues to rise in the EU, the European Commission is now considering feedback from European governments, regulators and industry on how changes to five aspects of the Orphan Regulation may further incentivize the development of drugs for rare diseases.

Categories: News, Europe, EC, EMA, MHRA, Drugs, Government affairs, Orphan products

Tags: orphan drugs, Orphan Regulation, EC consultation, rare disease drugs

Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge By Zachary Brennan - Published 04 March 2016

Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) on Thursday introduced a bill that would provide $5 billion per year in new funding for the Food and Drug Administration (FDA) and National Institutes of Health (NIH) as other legislation impacting FDA will be discussed and voted on in the coming week.

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

Tags: opioids, device regulation bill, pharmaceutical bill, FDA funding

Integrating FDA Meetings into a Medical Device Regulatory Strategy By Patrick Lee, RAC, Jack Douglas, PhD - Published 19 February 2016

An often overlooked opportunity for a successful device regulatory strategy is the optimal use of a pre-submission meeting with the regulatory agency. Meeting with the US Food and Drug Administration (FDA) to request feedback on specific submission issues has been formalized into what is collectively called the Q-Submission (Q-Sub) Program. A detailed description of the different types of FDA meetings is provided in FDA's Guidance document on Q-Subs.

Categories: Features, US, FDA, Communication, Medical Devices, Regulatory strategy, Submission and registration

Tags: Q-Submission, Q-Sub, Feedback, Novel Technology Regulation

Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions By Zachary Brennan - Published 03 February 2016

While the US Food and Drug Administration (FDA) sits on the fence over whether to approve preclinical or clinical trials using mitochondrial replacement techniques (MRT) to help prevent the transmission of certain diseases passed from mother to child, the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine came out with a new report on Wednesday detailing how it believes FDA should allow such trials and regulate them.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: MRT, mitochondrial DNA, inherited diseases, FDA regulation of MRT, CRISPR