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Filtering on: "topics government affairs"

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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

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

Markey and Warren Re-Intro Bill to Repeal Medical Device Tax By Zachary Brennan - Published 15 January 2018

Sens. Ed Markey (D-MA) and Elizabeth Warren (D-MA) re-introduced a bill from 2015 last week that would permanently repeal a 2.3% medical device tax that was delayed for two years but took effect at the beginning of this year.

Categories: News, US, Government affairs, Medical Devices

Tags: Elizabeth Warren, medical device tax

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 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

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

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

House E&C Offers Recommendations to Improve 340B Drug Pricing Program By Zachary Brennan - Published 10 January 2018

The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues related to the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients, and recommendations to improve the program’s administration.

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

Tags: HRSA, 340B, drug discount, House Energy & Commerce

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

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

HHS' OIG to PhRMA: Free Pharmaceuticals Needed in 2018 By Zachary Brennan - Published 05 January 2018

With a nonprofit that paid almost $100 million in 2015 financial grants to patients now saying that it will not offer such payments in 2018, Gregory Demske, chief counsel to the Department of Health and Human Services' Office of the Inspector General (OIG), sent a letter on Thursday seeking help from the pharmaceutical industry group PhRMA in providing free drugs.

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

Tags: PhRMA, CVC, drug charity, OIG

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

FDA Warns Fresenius Kabi API Manufacturing Plant By Zachary Brennan - Published 02 January 2018

The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi’s active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing

Tags: Fresenius, warning letter, API manufacturing

Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance By Zachary Brennan - Published 02 January 2018

Know the difference between a Type A, Type B and Type C meeting with the US Food and Drug Administration (FDA)? New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect.

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

Tags: formal FDA meetings, PDUFA VI, user fee goal dates for meetings, Type A meeting

Best Practices for IND Sponsor Communications: FDA Finalizes Guidance By Zachary Brennan - Published 02 January 2018

The US Food and Drug Administration (FDA) last week finalized guidance from 2015 on the best practices for communications between investigational new drug application (IND) sponsors and FDA.

Categories: News, US, FDA, Drugs, Government affairs, Research and development

Tags: IND sponsor communications, FDA guidance, PDUFA

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

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,

2.3% Tax on Medical Device Companies to Take Effect in 2018 By Zachary Brennan - Published 21 December 2017

As some companies cheer new tax cuts, medical device companies will ring in the new year with the reinstatement of a 2.3% tax put in place by the Affordable Care Act, after efforts to permanently repeal or delay the tax failed.

Categories: News, US, Government affairs, In vitro diagnostics, Medical Devices

Tags: device tax, Obamacare, medical device company tax

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

FDA Closes Loophole Companies Used to Skirt Pediatric Study Requirements By Zachary Brennan - Published 19 December 2017

The US Food and Drug Administration (FDA) on Tuesday released draft guidance indicating that it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases except for under certain conditions.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Government affairs, Orphan products, Research and development

Tags: pediatric research, orphan designation, pediatric subpopulation

GAO: Retail Drug Price Expenditures Have Nearly Doubled Since 1990s By Zachary Brennan - Published 19 December 2017

The US Government Accountability Office (GAO) on Tuesday released a new report on the pharmaceutical industry's sales and expenses related to research and development (R&D), noting that the amount of money people spend on prescription drugs has nearly doubled since the 1990s, mostly because of brand-name drugs.

Categories: News, US, DOJ, FDA, FTC, Biologics and biotechnology, Drugs, Government affairs, Research and development

Tags: GAO report, drug prices, R&D spending

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