Search Results for regulation

Showing 1 – 25  of 136

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

Device Industry Calls for Clarifications to Draft Animal Studies Guidance By Michael Mezher - Published 26 January 2016

The Advanced Medical Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices.

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

Tags: Animal studies, Good Laboratory Practice, Quality System Regulation

FDA Unveils New Office of Dietary Supplement Programs By Zachary Brennan - Published 21 December 2015

As part efforts to elevate the regulation of dietary supplements, the US Food and Drug Administration announced on Monday the creation of the new Office of Dietary Supplement Programs (ODSP).

Categories: News, US, FDA, Compliance, Distribution, Government affairs, Nutritional and dietary supplements, Quality

Tags: dietary supplements, supplement regulation, FDA and dietary supplements

EMA Outlines High-Level Strategy for Next Five Years By Zachary Brennan - Published 18 December 2015

Antimicrobial resistance, ensuring timely access to new drugs, increasing transparency and working to harmonize more regulations worldwide are all included in the European Medicines Agency’s (EMA) strategic plan through 2020.

Categories: News, Europe, EMA, Active pharmaceutical ingredients, Biologics and biotechnology, Business and Leadership, Clinical, Crisis management, Drugs, Ethics, Government affairs, Manufacturing, Orphan products, Regulatory intelligence, Regulatory strategy

Tags: EMA, medicines regulation, clinical trials, harmonized regulations

USP Signs Agreement With Russian Drug Regulator to Continue Developing Quality Standards By Zachary Brennan - Published 21 October 2015

The US Pharmacopeial Convention (USP) and Russia's medical products regulator forged a three-year memorandum of understanding (MOU) earlier this week that will focus on harmonizing major pharmacopeial requirements and promoting the use of modern laboratory standards, among other things.

Categories: News, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing, Quality

Tags: USP, Roszdravnadzor, Russian drug regulation, MOU, laboratory audits

EMA Gearing up to Publish Clinical Data Ahead of New Clinical Trials Regulation By Michael Mezher - Published 09 June 2015

The European Medicines Agency (EMA) is moving forward with its plan to release the clinical data used in marketing authorization applications.

Categories: News, Europe, EMA, Clinical, Government affairs, Preclinical, Submission and registration

Tags: Clinical trials regulation, Commercially confidential information

Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event By Zachary Brousseau - Published 29 May 2015

As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. RAPS’ virtual event Advertising, Promotion and Labeling: the US Regulated Environment will bring together experts to offer their advice.

Categories: HTML, Articles, Under RAPS, RAPS Events, US, FDA, FTC, RAPS, Advertising and Promotion, Compliance, Labeling

Tags: advertising, promotion, labeling, social media, social media regulation, FDA, FTC

FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs Published 22 May 2015

The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Packaging

Tags: FDC, Fixed-Dose Combination, Unified Agenda, Co-Packaged Drugs, Co-Packaged Biologics, Regulation, Proposed Rule, Final Rule