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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 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 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

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 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 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

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

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

FDA Warns Doctors of Collapsed Lungs and Deaths Possibly Linked to Feeding Tube Placement Devices By Zachary Brennan - Published 11 January 2018

The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers to provide information about reports of pneumothorax events, or collapsed lungs, and deaths associated with feeding tube placement procedures using some enteral access systems (EAS).

Categories: News, US, FDA, Crisis management, Due Diligence, Government affairs, Medical Devices

Tags: feeding tubes, EAS, collapsed lung

Device Recalls in 2017: Making Sense of the Numbers By Michael Mezher - Published 10 January 2018

Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death.

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

Tags: Recalls, Corrections, Removals, Class I Recall

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

New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety By Michael Mezher - Published 09 January 2018

A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms.

Categories: News, US, FDA, Communication, Drugs

Tags: Twitter, Facebook, Social Media, Safety Communications

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

HHS Secretary Nominee: 'No Silver Bullet' to Bring Down Drug Prices By Zachary Brennan - Published 09 January 2018

President Donald Trump's Department of Health and Human Services (HHS) Secretary nominee Alex Azar told the Senate Finance Committee on Tuesday that drug prices "are too high" and he will work to bring them down, though, "There's no silver bullet."

Categories: News, US, FDA, Drugs, Government affairs

Tags: drug prices, Alex Azar, Senate Finance

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

Researchers Pilot Ingestible Electronic Sensor to Monitor Microbiome By Zachary Brennan - Published 08 January 2018

Australian researchers have conducted a human trial that they say illustrated the potential role for electronic-based gas-sensing capsules in understanding aspects of the intestine and its microbiota in health, according to an article published online on Monday in Nature Electronics.

Categories: News, Oceania, US, FDA, Clinical, Drugs

Tags: electronic pill, ingestible sensor, Otsuka

Industry Groups Explain Competition Issues in the US Pharma Market By Zachary Brennan - Published 05 January 2018

Industry groups representing generic and brand-name drugs, pharmacy benefit managers (PBMs) and pharmacies offered their comments on a November meeting held at the Federal Trade Commission (FTC) on possible solutions to increase competition and lower drug prices in the US.

Categories: News, US, FDA, FTC, Generic drugs

Tags: drug prices, pharmaceutical competition

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

FDA Warns Stem Cell Supplier Over Unapproved Treatment By Michael Mezher - Published 04 January 2018

The US Food and Drug Administration (FDA) on Wednesday warned stem cell product supplier American CryoStem Corporation for marketing an unapproved product after the agency inspected the company's Eatontown, New Jersey site in July.

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

Tags: Stem Cell, American CryoStem, Atcell, Warning Letter

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

More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve By Zachary Brennan - Published 04 January 2018

The US Food and Drug Administration (FDA) on Thursday announced that shortages of IV saline are expected to improve early this year as Baxter – a leading producer of IV saline fluids – has said all its facilities on Puerto Rico have now returned to the commercial power grid.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs

Tags: drug shortages, Baxter, IV saline, Puerto Rico, Hurricane Maria

OPDP Letters: FDA Closes Out 2017 With Record Low By Michael Mezher - Published 03 January 2018

In the last days of 2017, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to over-the-counter (OTC) drugmaker Avanthi, Inc. for omitting risk information in a panel for the weight loss drug Lomaira (phentermine hydrochloride USP).

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

Tags: OPDP, Prescription Drug Promotion, Warning Letter