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Filtering on: "topics submission and registration"

Showing 1 – 25  of 583

EMA Begins Publishing Reports on Whether Approved Medicines Still Qualify as Orphans By Michael Mezher - Published 17 January 2018

The European Medicines Agency (EMA) on Wednesday announced it has begun publishing reports detailing its decision-making on whether newly approved drugs to treat rare diseases still qualify for orphan designation when they receive marketing authorization.

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

Tags: Orphan Medicine Assessment

GAO Calls on FDA to Evaluate its Efforts on Least Burdensome Approach for Devices By Michael Mezher - Published 17 January 2018

The Government Accountability Office (GAO) has told the US Food and Drug Administration (FDA) to develop metrics to evaluate its performance in implementing its least burdensome approach to regulating medical devices, according to a report released on Tuesday.

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

Tags: GAO, Government Accountability Office, Least Burdensome Provisions, FDAMA, 21st Century Cures

Brexit: MHRA Promises 'No Sudden Changes' to UK Regulations By Michael Mezher - Published 16 January 2018

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reassured drugmakers that there will be no sudden changes to the country's regulatory framework when it leaves the EU in March 2019.

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

Tags: Brexit

FDA Proposes Rule for Appealing CDRH Decisions By Michael Mezher - Published 16 January 2018

The US Food and Drug Administration (FDA) on Tuesday proposed a new rule for appealing certain decisions about medical devices made by the Center for Devices and Radiological Health (CDRH).

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

Tags: Significant Decisions, Supervisory Review, Appeals

FDA Denies Novo Nordisk Petition on Liraglutide Generics By Zachary Brennan - Published 08 January 2018

The US Food and Drug Administration (FDA) on Friday denied Novo Nordisk’s citizen petition that aimed to block generic versions of its blockbuster Victoza (liraglutide) and two other products containing liraglutide.

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

Tags: liraglutide, citizen petition, Victoza generic

CBER Director Highlights Firsts in FY2017 Report By Michael Mezher - Published 05 January 2018

In his second annual report as the director of the US Food Administration's (FDA) Center for Biologics Research and Evaluation(CBER), Peter Marks said the center continued to meet or exceed its performance goals in the final year of the last Prescription Drug User Fee Act (PDUFA V).

Categories: News, US, CBER, Biologics and biotechnology, Drugs, Submission and registration

Tags: PDUFA, CBER, Kymriah

One-Time Marketing Status Reports Due in February, FDA Says By Zachary Brennan - Published 03 January 2018

The US Food and Drug Administration (FDA) is calling on all new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale.

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

Tags: marketing status, user fee, FDARA, FDA status reports

Ruling Against Novartis Could Have Wider Implications for Generic Drug Labels By Zachary Brennan - Published 22 December 2017

California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels.

Categories: News, US, FDA, Drugs, Government affairs, Labeling, Regulatory strategy, Submission and registration

Tags: generic drug labels, label proposed rule, rulemaking

New Draft Guidance Looks to Update FDA's Replacement Reagent Policy for IVDs By Michael Mezher - Published 22 December 2017

In a new draft guidance released earlier this week, the US Food and Drug Administration (FDA) looks to update a 2003 policy that allows in vitro diagnostic makers to avoid having to submit a new 510(k) for certain changes to their tests.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: Replacement Reagent, Instrument Family, In VItro Diagnostics

Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High By Zachary Brennan - Published 21 December 2017

The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the highest number of NMEs approved in any year except 1996.

Categories: News, US, FDA, Drugs, Government affairs, Submission and registration

Tags: new drug approvals, new molecular entities, Addyi,

Updated: House and Senate Pass Tax Overhaul By Zachary Brennan - Published 20 December 2017

The US House of Representatives on Tuesday afternoon voted 227 to 203 in favor of passing the GOP's tax overhaul bill, with no Democrats voting for the bill and 12 Republicans voting against it. The Senate early Wednesday morning also passed the bill and then the House passed the bill again in a redo vote after several provisions had to be pulled for violations of the Byrd Rule.

Categories: News, US, Clinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: tax bill, Senate vote, House vote

Use of Standards at CBER: New Draft Guidance By Zachary Brennan - Published 18 December 2017

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday released draft guidance offering recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process.

Categories: News, US, CBER, Biologics and biotechnology, Submission and registration

Tags: standards, standards in regulatory submissions

FDA Discusses Device Least Burdensome Provisions in New Draft Guidance By Michael Mezher - Published 14 December 2017

After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices.

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

Tags: Least Burdensome, FDASIA, 21st Century Cures, Alternative 510(k) Pathway

Pfizer Not Planning US Launch of its Second Remicade Biosimilar Approved by FDA By Zachary Brennan - Published 14 December 2017

The US Food and Drug Administration (FDA) late Wednesday approved the ninth biosimilar in the US and the third for J&J’s Remicade (infliximab), but Pfizer said it will not launch Ixifi (infliximab-qbtx) in the US as the company already has another Remicade biosimilar on the market and known as Inflectra (infliximab-dyyb) (the third Remicade biosimilar is Merck and Samsung Bioepis’ Renflexis (infliximab-abda)).

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

Tags: Pfizer, Inflectra, Remicade, J&J, Ixifi

Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation By Yvonne Middlefell, FRAPS, RAC - Published 12 December 2017

This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use.

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

Tags: IVDR, Annex 1, Risk Management

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

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

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

FDA Finalizes Guidance to Help CMS With Coverage Decisions on Devices By Zachary Brennan - Published 04 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance meant to assist the Centers for Medicare and Medicaid Services (CMS) in determining whether or not an investigational device should be reimbursed by CMS.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: CMS coverage of medical devices, FDA guidance

CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation By Jonathan Bray, PhD, Michelle O'Connor, PhD, Robert D. Cumming - Published 01 December 2017

This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system.1 The regulations, intended to affect greater IVD safety and reliability, expand the definition of an IVD to include software used as any part of an IVD, as well as an IVD used for providing information concerning the predisposition to a medical condition or disease. An IVD also may be a device used to predict a treatment response or reaction to a treatment. Moving forward, all Class B through Class D IVDs will require some level of conformity assessment by an independent Notified Body.

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

Tags: MDR, IVDR, CE Marking

FDA, CMS: Second Parallel Review Decision Ever for NGS Test By Michael Mezher - Published 01 December 2017

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test.

Categories: News, US, FDA, In vitro diagnostics, Reimbursement, Submission and registration

Tags: Parallel Review, CMS, FoundationOne CDx, Breakthrough Device

Abuse-Deterrent Opioids: FDA Finalizes Guidance for Generics By Michael Mezher - Published 29 November 2017

The US Food and Drug Administration (FDA) last week finalized guidance detailing its expectations for drugmakers looking to develop generic versions of abuse-deterrent opioids.

Categories: News, FDA, Drugs, Submission and registration

Tags: Abuse-Deterrent Opioids

FDA Finalizes Guidance on Minimizing X-Ray Radiation for Children By Michael Mezher - Published 29 November 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at reducing the amount of radiation children are exposed to from x-ray imaging devices.

Categories: News, FDA, Labeling, Medical Devices, Submission and registration

Tags: X-Ray Imaging, Radiation

FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions By Michael Mezher - Published 28 November 2017

The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the Clinical Laboratories Improvement Amendments (CLIA) in line with provisions of the 21st Century Cures Act and the recently reauthorized Medical Device User Fee Amendments (MDUFA IV).

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: CLIA Waiver, CLIA Waiver by Application, IVDs, Dual Submissions