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Filtering on: "topics drugs over the counter drugs"

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Public Citizen Sues FDA Over OTC Drug Risks By Michael Mezher - Published 21 September 2017

Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine.

Categories: News, US, FDA, Over the counter drugs

Tags: Benzocaine, Teething, Methemoglobinemia, Public Citizen, OTC Monograph

Congress Takes First Look at User Fee Program for OTC Drugs By Michael Mezher - Published 13 September 2017

The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products.

Categories: News, US, FDA, Over the counter drugs

Tags: OTC Monograph, OMOR, Over-the-Counter Monograph, User Fees

FDA Warns Chinese OTC Drugmaker for GMP, Data Integrity Issues By Michael Mezher - Published 24 August 2017

The US Food and Drug Administration (FDA) has warned Chinese over-the-counter (OTC) drug and cosmetics maker Bicooya Cosmetics Limited over poor sanitary conditions and data integrity issues at its Zhejiang, China facility.

Categories: News, China, US, FDA, Over the counter drugs, Manufacturing

Tags: Warning Letter, Inspection, Data Integrity

FDA Warns Chinese Manufacturer for GMP, Training Issues By Michael Mezher - Published 15 August 2017

The US Food and Drug Administration (FDA) has warned Chinese manufacturer Foshan Flying Medical Products for testing and validation issues at its Guangdong, China facility.

Categories: News, China, US, FDA, Compliance, Over the counter drugs

Tags: Warning Letter, GMP

FDA Details Draft Goals for OTC Monograph User Fee Program By Michael Mezher - Published 01 August 2017

After a series of discussions with industry and a public meeting in June 2016, the US Food and Drug Administration (FDA) last week released its draft goals letter for the proposed over-the-counter (OTC) monograph user fee program.

Categories: News, US, FDA, Over the counter drugs

Tags: OTC Monograph, User Fees, OMUFA

Updated: FDA Warns OTC Drugmaker for Inaccurate Listing Information By Michael Mezher - Published 06 June 2017

The US Food and Drug Administration (FDA) on Thursday warned over-the-counter drugmaker Prestige Brands Holdings over missing information in the structured product labeling (SPL) submitted to FDA for two of the company's drugs.

Categories: News, US, FDA, Over the counter drugs, Labeling

Pfizer Proposes to Make Viagra Available in the UK Without a Prescription By Zachary Brennan - Published 29 March 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a Pfizer proposal calling to make the popular erectile dysfunction drug sildenafil (more commonly known as Viagra) available without a prescription at UK pharmacies.

Categories: News, Europe, MHRA, Over the counter drugs

Tags: Pfizer, Viagra, Cialis, over the counter drugs, erectile dysfunction

FDA Issues Labeling Guidance for Aspirin, Acetaminophen By Michael Mezher - Published 10 January 2017

The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC acetaminophen-containing products.

Categories: News, US, FDA, Over the counter drugs, Labeling, Packaging

Tags: Aspirin, Acetaminophen

FTC Plans Crackdown on Marketing Claims of OTC Homeopathic Drugs By Zachary Brennan - Published 15 November 2016

The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims.

Categories: News, US, FTC, Advertising and Promotion, Over the counter drugs, Due Diligence, Quality

Tags: drug marketing, OTC drugs, homeopathic drugs

Health Canada Looks to Raise the Bar for Regulating Natural Health Products By Zachary Brennan - Published 04 October 2016

A controversial new proposal from Health Canada would add new regulatory scrutiny for natural health products and bring them in line with higher scientific standards used to regulate over-the-counter drugs.

Categories: News, Canada, Health Canada, Cosmetics, Over the counter drugs, Nutritional and dietary supplements

Tags: Health Canada, natural health products, cosmetics, OTC drugs, non-prescription drugs

FDA Warns Brazilian OTC Drug Manufacturer By Zachary Brennan - Published 04 October 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Brazil’s Mappel Industria de Embalagens last month for four violations, though the over-the-counter (OTC) drug manufacturer told FDA that it did not realize the products were regulated by FDA.

Categories: News, Latin America and Caribbean, US, FDA, Compliance, Crisis management, Over the counter drugs, Ethics, Manufacturing

Tags: warning letter, Brazil OTC drugs, OTC drug regulations

FDA to Restrict Compounders from Making Copies of Commercially Available Drugs By Zachary Brennan - Published 07 July 2016

The US Food and Drug Administration (FDA) on Thursday issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Over the counter drugs, Prescription drugs, Manufacturing, Quality

Tags: drug compounding, FDA guidance on compounding

What's Happening Down Under? The Australian Regulatory Scene in 2016 By Clive Simon, PhD, MBA - Published 13 June 2016

This article discusses the current regulatory framework for drugs and medical devices in Australia, compares differences in regulatory processes between Australia, the US and the EU and predicts future developments and challenges for industry and regulators.

Categories: Features, Oceania, TGA, Biologics and biotechnology, Cosmetics, Over the counter drugs, Prescription drugs, Human cell and tissue, In vitro diagnostics, Medical Devices, Veterinary products

Understaffed and Underfunded: FDA Begins to Hear Opinions on Crafting an OTC Drug User Fee Program By Zachary Brennan - Published 10 June 2016

With only 18 full-time employees working to oversee an over-the-counter (OTC) drug monograph program covering hundreds of thousands of products, the US Food and Drug Administration (FDA) is beginning to evaluate different perspectives on creating a new user fee program to help, particularly as congressional appropriations have remained stagnant over the past few years.

Categories: News, US, FDA, Crisis management, Over the counter drugs, Government affairs, Postmarket surveillance, Regulatory strategy

Tags: OTC drug user fee, OTC monographs, FDA user fee programs

Boehringer Ingelheim Warns MHRA of Reckitt Benckiser’s Misleading TV Advertisement By Zachary Brennan - Published 06 June 2016

It’s well known that competition among pharmaceutical companies is fierce, and a misstep, usually in a clinical trial, can result in millions, if not billions of dollars lost. And now a glimpse of that competition is boiling over into the realm of television advertising.

Categories: News, Europe, MHRA, Advertising and Promotion, Over the counter drugs

Tags: Senokot, Reckitt Benckiser, Boehringer Ingelheim, Dulcolax, laxative, OTC drug television advertisements

Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk By Zachary Brennan - Published 06 June 2016

The US Food and Drug Administration (FDA) on Monday warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid drugs to treat heartburn, sour stomach, acid indigestion or upset stomach.

Categories: News, US, FDA, Over the counter drugs, Postmarket surveillance

Tags: aspirin, heartburn, OTC drug safety communications, nonprescription drugs

New Bill Would Speed FDA Review of OTC Contraceptives By Michael Mezher - Published 10 May 2016

A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women.

Categories: News, US, FDA, Over the counter drugs, Prescription drugs, Submission and registration

Tags: Contraceptive mandate, Affordable Care Act, Rep. Mia Love (R-UT), Guttmacher Institute

Final FDA Guidance on Drug Design Seeks to Reduce Medication Errors By Michael Mezher - Published 11 April 2016

The US Food and Drug Administration has finalized guidance detailing best practices on how to improve a drug's container closure system to minimize the risk of medication errors.

Categories: News, US, FDA, Biologics and biotechnology, Generic drugs, Over the counter drugs, Prescription drugs

Tags: Medication errors

Asia Regulatory Roundup: China Focuses on Generic Drug Quality, Efficacy (8 March 2016) By Nick Paul Taylor - Published 08 March 2016

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

Categories: News, Asia, CDSCO, CFDA, Medsafe, PMDA, Biologics and biotechnology, Compliance, Generic drugs, Over the counter drugs, Government affairs, Medical Devices

Tags: Asia Regulatory Roundup, India online portal, OTC applications

FDA Advisory Committee Calendar By Tarius - Published 05 September 2017

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Generic drugs, Over the counter drugs, Prescription drugs, Postmarket surveillance

Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees

TGA Weighs Rescheduling Codeine Following Safety Review By Michael Mezher - Published 01 October 2015

Codeine-containing medicines may soon be available by prescription only in Australia, following a review and public consultation by the Therapeutic Goods Administration (TGA).

Categories: News, Oceania, TGA, Active pharmaceutical ingredients, Over the counter drugs, Prescription drugs, Government affairs

Tags: Poisons Standard, SUSMP, codeine

FTC Asks FDA to Reevaluate Framework for Homeopathic Products By Michael Mezher - Published 24 August 2015

The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient.

Categories: News, US, FDA, FTC, Advertising and Promotion, Over the counter drugs, Labeling

Tags: Federal Trade Commission, FTC, Homeopathy, Homeopathic

Natural Health Products Excluded From Vanessa's Law By Michael Mezher - Published 11 May 2015

Following the recall of two herbal medicines for containing high levels of lead and arsenic, The Globe and Mail is questioning why a new drug safety law excludes natural health products from its provisions.

Categories: News, Canada, Health Canada, Over the counter drugs, Government affairs, Manufacturing, Nutritional and dietary supplements, Postmarket surveillance, Quality

Tags: Vanessa's Law, Natural health products, herbal remedies

EU Committee Confirms Increased Risk with Ibuprofen at High Doses By Michael Mezher - Published 13 April 2015

A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient's risk for cardiovascular issues.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Over the counter drugs, Prescription drugs, Postmarket surveillance

Tags: Ibuprofen, NSAIDs, PRAC, Pharmacovigilance Risk Assessment Committee

UK Regulator Releases Advertising Report, Complaints Down 32% from 2013 By Michael Mezher - Published 25 February 2015

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its annual report on drug advertising. The agency says complaints are down versus previous years, but notes it received more complaints about advertisements made on websites and social media.

Categories: News, Europe, MHRA, Advertising and Promotion, Over the counter drugs, Prescription drugs, Government affairs

Tags: Advertising and Promotion, Social Media