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Filtering on: "topics regulatory strategy"

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GAO to FDA: Publish Plans to Issue or Revise Guidance on Complex Generic Drugs By Zachary Brennan - Published 16 January 2018

The US Government Accountability Office (GAO) on Tuesday called on the US Food and Drug Administration (FDA) to announce plans to issue or revise guidance for complex generic drugs and FDA said it agrees with the recommendation and is working toward that goal.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: complex generics, GAO report

Transparency: FDA to Release Portions of Redacted Clinical Study Reports By Zachary Brennan - Published 16 January 2018

As part of a push to be more transparent about its decision making, the US Food and Drug Administration (FDA) on Tuesday announced it will launch a pilot project to publicly release portions of clinical trial-related summaries from the pivotal trials that were submitted to the FDA by the drug’s sponsor.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: FDA transparency, Johns Hopkins, Gottlieb

FDA and Pentagon Forge Breakthrough Designation Agreement By Zachary Brennan - Published 16 January 2018

Following the Pentagon’s criticism of the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have used for years, FDA and the Department of Defense’s (DoD) Office of Health Affairs on Tuesday launched a joint program to prioritize the efficient development of such medical products.

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

Tags: Pentagon, DoD, breakthrough, freeze-dried plasma, platelets

FDA Looks Ahead and Back on Orally Inhaled and Nasal Generic Drugs By Zachary Brennan - Published 15 January 2018

The US Food and Drug Administration (FDA) has come a long way when it comes to locally acting orally inhaled and nasal drug products (OINDPs) and in the next five years of generic drug user fees, the agency is looking at further progress on some unique challenges, according to a regulatory science report on OINDPs.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: OINDP, locally acting orally inhaled and nasal drug products

FDA Plots Policy Priorities for 2018 By Zachary Brennan - Published 11 January 2018

The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: generic competition, total product lifecycle, opioids

EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments By Zachary Brennan - Published 10 January 2018

The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA).

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: rheumatoid arthritis, EMA guideline

CDER Report on Novel Approvals Highlights Firsts in 2017 By Zachary Brennan - Published 10 January 2018

2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties.

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

Tags: 2017 novel drug approvals, CDER report, Woodcock, Gottlieb

FDA Denies Amneal Petition Seeking to Block Generic Versions of Osteoporosis Treatment By Zachary Brennan - Published 09 January 2018

Capping a string of recent citizen petition denials, the US Food and Drug Administration (FDA) has rejected Amneal Pharmaceuticals' citizen petition asking the agency to refrain from approving any abbreviated new drug applications (ANDAs) for the blockbuster osteoporosis treatment Forteo (teriparatide).

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Forteo, osteoporosis, Amneal, Lilly, citizen petitions

Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says By Zachary Brennan - Published 09 January 2018

Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they?

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: parallel review, Shuren, MOU

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

FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics By Zachary Brennan - Published 04 January 2018

The US Food and Drug Administration (FDA) on Wednesday denied Allergan's third citizen petition attempting to block the agency from approving generic versions of the company's blockbuster Restasis (cyclosporine ophthalmic emulsion).

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

Tags: Restasis, Allergan, Mylan, Citizen Petition

FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP By Zachary Brennan - Published 03 January 2018

Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: ANDA review cycles, generic drug guidance, MAPP

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

Perspective: Regulatory Bill Could be Dangerous for FDA, Public Health By Zachary Brennan - Published 21 December 2017

A bill making its way through Congress could end up having "potentially disastrous consequences" for the US Food and Drug Administration (FDA) and public health, professors from the Program on Regulation, Therapeutics, and Law at Harvard Medical School and the Georgia State University College of Law, wrote in the New England Journal of Medicine this week.

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

Tags: regulations, Regulatory Accountability Act, FDA rulemakings

Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance By Zachary Brennan - Published 20 December 2017

Drugmakers Sanofi and Teva, alongside industry groups AAM and the Bulk Pharmaceuticals Task Force, offered their comments earlier this month on new draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: ANDA formal meetings, FDA draft guidance, SOCMA, Teva, Sanofi

Best of 2017: What Readers Clicked on This Year By Zachary Brennan - Published 20 December 2017

From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Trump, biosimilars, Micro Therapeutic Research Labs, Truvada

Asia Regulatory Roundup: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines (19 December 2017) By Nick Paul Taylor - Published 19 December 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CFDA, TGA, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, adverse event, clinical trials China

FDA Approves New Gene Therapy Targeting Specific Mutation By Zachary Brennan - Published 19 December 2017

The US Food and Drug Administration (FDA) on Tuesday approved a new gene therapy from Spark Therapeutics for the treatment of children and adult patients with an inherited form of vision loss that may result in blindness.

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

Tags: gene therapy, Luxturna, blindness, Spark Therapeutics

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

FDA Plots New Enforcement Approach for Homeopathic Products By Zachary Brennan - Published 18 December 2017

The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic.

Categories: News, FDA, Compliance, Crisis management, Nutritional and dietary supplements, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: homeopathic, FDA enforcement, FDA draft guidance

FDA to Begin Issuing Deficiency Review Letters to Generic Drugmakers By Zachary Brennan - Published 15 December 2017

The US Food and Drug Administration (FDA) on Friday published draft guidance that would establish a new type of letter the agency sends to generic drugmakers to provide applicants with preliminary thoughts on possible deficiencies of an abbreviated new drug application (ANDA).

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: DRLs, CRLs, information requests, GDUFA II

FDA Offers Two New Draft Guidances on Developing Targeted Therapies By Zachary Brennan - Published 15 December 2017

The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address the underlying genetic mutations that often cause or contribute to diseases and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from the drug study.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, In vitro diagnostics, Regulatory intelligence, Regulatory strategy

Tags: tumor agnostic approvals, investigational IVDs, genetic mutation

European Regulatory Roundup: Critical Moment for EMA (15 December 2017) By Nick Paul Taylor - Published 15 December 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

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

Tags: European Regulatory Roundup, Brexit, pediatric rare disease

What's Coming in 2018: FDA's Regulatory Agenda By Zachary Brennan - Published 15 December 2017

The US Food and Drug Administration (FDA) published its fall 2017 agenda of proposed and final rulemakings this week, with several expected on drug compounding, allowing foreign clinical data to bring medical devices to market and new ways to market nonprescription drugs.

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

Tags: proposed rulemaking, final rulemaking, regulatory agenda