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Regulatory Recon: Government Shutdown Looms; First PARP Inhibitor Approved in Japan (19 January 2018) By Zachary Brennan - Published 19 January 2018

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, EC, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA Unveils Plan for CDER Draft Guidance in 2018 By Zachary Brennan - Published 19 January 2018

The plan for 2018 guidance documents from the US Food and Drug Administration (FDA) includes more than 10 guidance documents designated under several categories, including FDA procedures, pharmaceutical quality/chemistry, manufacturing and controls (CMC) and clinical/medical.

Categories: News, US, CDER, Drugs

Tags: draft guidance

Elemental Impurities Deadline Contributes to Spike in CRLs for Generic Drugmakers By Zachary Brennan - Published 19 January 2018

New generic drug applications are not winning a lot of approvals from the US Food and Drug Administration (FDA) so far this year and at least part of the reason for the increase in complete response letters (CRLs) is a new requirement from the US Pharmacopeia (USP).

Categories: News, US, FDA, Generic drugs

Tags: generic drugs, CRLs

The Battle Over Neulasta Biosimilars in the US: What's Coming in 2018 By Zachary Brennan - Published 18 January 2018

2016 and 2017 were difficult years for companies trying to win US Food and Drug Administration (FDA) approval for biosimilars of Amgen's blockbuster for treating side effects from chemotherapy.

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

Tags: Neulasta, Mylan, Coherus, Amgen, 340B

European Regulatory Roundup: MHRA Rolls Out Online Portal to Streamline Medical Device Regulatory Services (18 January 2018) By Nick Paul Taylor - Published 18 January 2018

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs

Tags: kidney, MHRA portal

Regulatory Recon: Kite Teams Up With Pfizer on Lymphoma Combo; Fed Up With Drugmakers, Hospitals Start Their Own (18 January 2018) By Michael Mezher - Published 18 January 2018

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance By Michael Mezher - Published 18 January 2018

The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight.

Categories: News, US, FDA, Manufacturing

Tags: Compounding, Outsourcing Facilities, cGMP, Good Manufacturing Practice, Drug Quality and Security Act, DQSA

FDA Warns 5 Drugmakers in China, Australia and Austria By Zachary Brennan - Published 18 January 2018

The five warning letters sent from the US Food and Drug Administration (FDA) in December and January deal with violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients (APIs).

Categories: News, US, CDER, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: warning letter, cGMP violations

FDA Offers Recommendations on Highlights Section of Labeling By Michael Mezher - Published 18 January 2018

The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics.

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

Tags: Highlights, Prescribing Information, Physician Labeling Rule

The Next Emflaza: Acer Therapeutics Looks to Take a Page Out of Marathon's Book By Zachary Brennan - Published 18 January 2018

Last year, Marathon Pharmaceuticals took an inexpensive steroid available for sale in the EU and Canada and brought it through the US Food and Drug Administration's (FDA) approval process before trumpeting an $89,000 annual price.

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

Tags: Emflaza, Marathon, Acer, Shkreli

CDRH Looks Ahead to Priorities for 2018 to 2022 By Zachary Brennan - Published 17 January 2018

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced Wednesday that it has met its three strategic goals from 2016 and 2017 and it has outlined three more for 2018 to 2022.

Categories: News, US, CDRH, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: novel devices, UDI, NGS

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

Regulatory Recon: Celgene in Talks to Buy Juno; Chinese Investors Eye J&J's Diabetes Business (17 January 2018) By Michael Mezher - Published 17 January 2018

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

FDA Drafts PRV Guidance for Medical Countermeasures By Zachary Brennan - Published 17 January 2018

The US Food and Drug Administration (FDA) on Wednesday released new draft guidance to help companies understand how the agency will award priority review vouchers (PRVs) for qualifying medical products to diagnose, prevent or treat diseases or conditions associated with chemical, biological, radiological and nuclear (CBRN) threats and emerging infectious diseases.

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

Tags: priority review voucher, PRV, medical countermeasures

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

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

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

FDA Warns Imprimis for False and Misleading Website and Twitter Promotions By Zachary Brennan - Published 16 January 2018

The US Food and Drug Administration (FDA) late last month sent a warning letter to San Diego-based Imprimis Pharmaceuticals for false and misleading claims made on the company’s website and Twitter account, among other violations.

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

Tags: Imprimis, Twitter, FDA warning letters

Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018) By Nick Paul Taylor - Published 16 January 2018

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, black triangle, device data, recalls

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

Regulatory Recon: Merck's Keytruda Combo Extends Survival in Lung Cancer Trial; Sandoz Files Humira Biosimilar for US Approval (16 January 2018) By Michael Mezher - Published 16 January 2018

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

Regulatory Recon: Google Backs UK Universal Vaccine Company; Shire Wins EU Approval for Long Acting Hemophilia A Treatment (15 January 2018) By Michael Mezher - Published 15 January 2018

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News