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FDA Unveils Plan for CDER Draft Guidance in 2018 By Zachary Brennan - Published 19 January 2018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Tags: draft guidance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

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

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

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

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 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 Details New Manufacturing Quality Pilot Program By Michael Mezher - Published 15 January 2018

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative.

Categories: News, US, FDA, Manufacturing, Medical Devices, Quality

Tags: Case for Quality, Pilot

FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices By Zachary Brennan - Published 12 January 2018

The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices

Tags: unique device identification, Class I, unclassified devices, UDI enforcement

FTC Settles Complaint Over Deceptive Marketing of Unapproved Cancer Products By Michael Mezher - Published 12 January 2018

The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products.

Categories: News, US, FDA, FTC, Advertising and Promotion

Tags: FTC, Federal Trade Commission, CellMark

FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation By Michael Mezher - Published 12 January 2018

After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May, the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes.

Categories: News, FDA, In vitro diagnostics, Medical Devices

Tags: BD, LeadCare, Magellan Diagnostics, Vacutainer, Warning Letter

FDA Delays Implementing Parts of 'Intended Use' Rule By Zachary Brennan - Published 12 January 2018

Confusion and concerns over portions of a tobacco-related final rule that could have major ramifications for the medical product industries has pushed the US Food and Drug Administration (FDA) to delay the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used.

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

Tags: intended use, First Amendment, FDA rule

FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children By Zachary Brennan - Published 11 January 2018

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Labeling

Tags: codeine, cough and cold, hydrocodone

ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable By Zachary Brennan - Published 11 January 2018

The International Coalition of Medicines Regulatory Authorities (ICMRA) is focusing on aligning existing and planned track and trace systems worldwide, with an eye toward interoperability as many of the existing and planned systems were designed with a national or regional focus.

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Quality, Regulatory intelligence

Tags: ICMRA, track and trace, interoperability

Bioethicists Say Federal Right-to-Try Legislation Will Have Limited Impact on Access By Michael Mezher - Published 11 January 2018

In a perspective published in the New England Journal of Medicine on Wednesday, bioethicists Holly Fernandez Lynch and Steven Joffe of the University of Pennsylvania warn that federal "right-to-try" legislation could undermine the US Food and Drug Administration's (FDA) public health mission and will have a limited impact on improving patient access to investigational products.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Ethics

Tags: Right-to-Try, Expanded Access