Search Results for citizen petition

Showing 1 – 25  of 33

Petition to FDA Seeks to Modify Trial Regulations Following Deaths By Zachary Brennan - Published 18 May 2017

A petition submitted to the US Food and Drug Administration (FDA) in 2016 has been updated recently, as it seeks to reform FDA requirements for investigational new drug (IND) applications, investigational device exemptions (IDEs) and new drug applications (NDAs).

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: citizen petition, FDA petition, clinical trial regulations

Law Firm Challenges FDA on Combination Product Appeals By Michael Mezher - Published 09 March 2017

Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products.

Categories: News, US, FDA, Combination products, Submission and registration

Tags: Citizen Petition, Request for Designation, 21st Century Cures Act

FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition By Michael Mezher - Published 14 February 2017

The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: Durezol, Difluprednate Ophthalmic Emulsion, Alcon, Novartis, Citizen Petition, Bioequivalence

Public Citizen Petitions FDA to Pull Some IV Solutions By Zachary Brennan - Published 08 February 2017

Consumer advocacy organization Public Citizen on Wednesday petitioned the US Food and Drug Administration (FDA) to immediately require the removal of hydroxyethyl starch (HES) intravenous (IV) solutions from the market because their risks outweigh their limited benefits and there are other, safer alternative IV solutions.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Product withdrawl and retirement

Tags: HES IV solutions, citizen petition, Public Citizen, IV safety

Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic By Zachary Brennan - Published 28 September 2016

Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Medical Devices, Regulatory strategy

Tags: Mylan, Teva, EpiPen, Patty Murray, citizen petition, pay-for-delay settlement

In Petition to FDA, AbbVie Argues Biosimilars Need Distinctive Labeling By Alexander Gaffney, RAC - Published 04 June 2015

"Biosimilars are not generic drugs and should not be labeled like generic drugs," US pharmaceutical giant AbbVie argues in a new Citizen Petition sent to the US Food and Drug Administration (FDA) this week.

Categories: News, US, CDER, Biologics and biotechnology, Labeling

Tags: Biosimilars, Biosimilar Labeling, Citizen Petition, 505(q) Petition

Group Asks FDA for More Warning Information on Dietary Supplement Labels By Alexander Gaffney, RAC - Published 16 March 2015

A public health group is calling on the US Food and Drug Administration (FDA) change the warning labels on all herbal and dietary supplements to include more information about how the products might cause side effects, interact with pharmaceuticals and affect pregnant women.

Categories: News, US, FDA, Labeling, Nutritional and dietary supplements, Postmarket surveillance

Tags: Citizen Petition

FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show By Alexander Gaffney, RAC - Published 18 November 2014

A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking.

Categories: News, US, CDER, Generic drugs, Regulatory strategy, Submission and registration

Tags: ANDA, Abbreviated New Drug Application, 505(b)(2) Application, 505(q) Petition, Citizen Petition

Company, Warned by FDA Over Improper Marketing, Petitions Regulators for Redress By Alexander Gaffney, RAC - Published 27 October 2014

Most Warning Letters sent by the US Food and Drug Administration (FDA) are met by their recipients with a sense of loathing and urgency. A failure to respond to a letter quickly and appropriately can lead to major sanctions against a company, to say nothing of the damage a bungled response can do to a company's reputation.

Categories: News, US, FDA, Advertising and Promotion, Nutritional and dietary supplements

Tags: Citizen Petition, Warning Letter, Ebola

Public Citizen Again Calls for Ban on Diabetes Drug Victoza By Alexander Gaffney, RAC - Published 06 June 2014

A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths.

Categories: News, US, CDER, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: Novo Nordisk, Victoza, GLP-1, Public Citizen, Petition, Safety

FDA Says Abuse-Deterrence Equivalence Guidance is Under Development By Alexander Gaffney, RAC - Published 25 March 2014

Categories: US, FDA

Tags: Abuse-Deterrence Guidance, Purdue, OxyContin, oxycodone, Citizen Petition, Latest News, guidance

FDA Looks to Close Loophole That Could Delay Approval of Biosimilars By Alexander Gaffney, RAC - Published 10 March 2014

Categories: US, FDA

Tags: 351(k), 505(q), FDASIA, Citizen Petition, Latest News, FDAAA, biosimilar, FD&C Act

J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Sun Pharma, Orange Book, Janssen, J&J, Lipodox, Doxil, RLD, ANDA, Citizen Petition, Latest News, NDA

Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed By Alexander Gaffney, RAC - Published 26 February 2014

Categories: US, FDA

Tags: Boxed Warning, Testosterone, Low-T, Public Citizen, Citizen Petition, Black Box Warning, Latest News

FDA Issues Change to Make it Easier to Submit Citizen Petitions By Alexander Gaffney, RF News Editor - Published 18 December 2013

Categories: US, FDA

Tags: Citizen Petition, electronic, submission

FDA Denies Petition on Guidance for Single Shared REMS, but Agency May Issue in Future By Alexander Gaffney, RF News Editor - Published 22 October 2013

Categories: US, FDA

Tags: Prometheus, Citizen Petition, REMS

With Competition Close on the Horizon, Suboxone Manufacturer Files Challenge With FDA By Alexander Gaffney, RF News Editor - Published 09 September 2013

Categories: US, FDA

Tags: Citizen Petition

Human Rights Group to FDA: Reglan Needs New Restrictions, REMS to Prevent Use at Guantanamo Bay By Alexander Gaffney, RF News Editor - Published 05 September 2013

Categories: US, FDA

Tags: Citizen Petition

Citizen Petition: Prescription Status of Prosthetics Violates Americans with Disabilities Act By Alexander Gaffney, RF News Editor - Published 27 August 2013

Categories: US, FDA

Tags: Citizen Petition, medical device

Group to FDA: Use Enforcement Discretion to Allow Pediatric Labeling Updates on OTC Tylenol By Alexander Gaffney, RF News Editor - Published 21 August 2013

Categories: US, FDA

Tags: OTC, Citizen Petition

FDA Finalizes Decision Permitting Sale of Non-Abuse-Resistant Copies of Opana ER By Alexander Gaffney, RF News Editor - Published 24 June 2013

Categories: US, FDA

Tags: Citizen Petition

Asthma Patient Group Petitions FDA to Keep Products out of Novel OTC Switch Paradigm By Alexander Gaffney, RF News Editor - Published 20 June 2013

Categories: US, FDA

Tags: Citizen Petition

Citizen Petition Claims Lab-Developed Tests aren't Devices and are Beyond FDA Regulation By Alexander Gaffney, RF News Editor - Published 06 June 2013

Categories: US, FDA

Tags: Laboratory-Developed Tests, ACLA, CLIA, Lab-Developed Tests, LDT, Laboratory, Citizen Petition, Latest News

Prometheus Slams FDA for Lack of REMS Clarity as Agency Shows Signs of Conceding By Alexander Gaffney, RF News Editor - Published 29 May 2013

Categories: US, FDA

Tags: Citizen Petition, Prometheus Laboratories, REMS

Citing Public Health Needs, FDA Alters Labeling Standards for Smoking Cessation Products By Alexander Gaffney, RF News Editor - Published 01 April 2013

Categories: US, FDA, CDER

Tags: Citizen Petition, Tobacco, Smoking