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Filtering on: "topics drugs over the counter drugs"

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The US Food and Drug Administration (FDA) on Tuesday issued one draft guidance recommending a label advisory for over-the-counter (OTC) products containing aspirin, and finalized another recommending a warning label for OTC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

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

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 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The US Food and Drug Administration (FDA) on Thursday issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.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 15 February 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

Under Pressure from Congress, FDA Holds Firm on Rejection of new Sunscreen Ingredients By Alexander Gaffney, RAC - Published 24 February 2015

Despite congressional pressure to approve several new sunscreen ingredients long pending before reviewers, the US Food and Drug Administration (FDA) says it will not bow to pressure and will instead continue to insist the companies provide it with data to show the products are both safe and effective.

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

Tags: Sunscreen, Sunscreen Innovation Act, SIA, TEA, Time and Extent Application

Taiwan Regulators in Push to Switch More Drugs to OTC Status By Michael Mezher - Published 20 January 2015

The Taiwan Food and Drug Administration (TFDA) announced this month that it will be reclassifying 13 prescription drugs to be available over the counter (OTC), the Taipei Times reports. The move is part of a larger push in Taiwan to improve access to basic medicines and reduce healthcare spending.

Categories: Taiwan, Over the counter drugs

Tags: Taiwan, Over-the-Counter, OTC

UK's MHRA Puts New Restrictions on Popular Painkiller By Michael Mezher - Published 14 January 2015

A widely used over-the-counter painkiller has been reclassified as a prescription-only medicine (POM) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Categories: News, Europe, MHRA, Over the counter drugs, Prescription drugs, Labeling, Postmarket surveillance

Tags: Diclofenac, Painkiller, OTC, Legal Status P, Over-the-Counter

FDA Orders New Warnings on OTC Acetaminophen Drugs By Alexander Gaffney, RAC - Published 01 December 2014

A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions.

Categories: News, CDER, Over the counter drugs, Postmarket surveillance

Tags: Acetaminophen, Draft Guidance, Labeling, Warning, Skin Reactions

Obama Approves Bill Reforming Regulation of Sunscreen Ingredients, Other Drugs By Alexander Gaffney, RAC - Published 01 December 2014

US President Barack Obama has signed into law a new bill set to change the way in which some drugs, and in particular sunscreen ingredients long approved in other countries, are regulated by the US Food and Drug Administration (FDA).

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

Tags: Sunscreen Innovation Act, SIA, TEA, Time and Extent Application, Bill, Legislation, Barack Obama, President Obama

Legislators Call on FDA to Study use of Plastic Microbeads in Toothpastes By Alexander Gaffney, RAC - Published 17 November 2014

Two US legislators are calling on the US Food and Drug Administration (FDA) to assess the "potential risks" associated with the use of polyethylene microbeads in consumer care products, including toothpastes, saying the products could pose a risk to public health.

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

Tags: Microbeads, Legislators, Frank Pallone, Kirsten Gillibrand, Polyethylene Microbeads, Toothpaste

Bill to Speed up Approvals for Sunscreen Ingredients, Other Drugs Awaits Obama's Signature By Alexander Gaffney, RAC - Published 14 November 2014

US legislators in the House of Representatives have passed a Senate bill which would overhaul the manner in which the US Food and Drug Administration (FDA) approves sunscreen ingredients and other products through a rarely used regulatory pathway known as the Time-and-Extent process (TEA), all but assuring the bill will be passed into law.

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

Tags: Congress, House, Senate, Sunscreen Innovation Act, Sunscreen, Legislation, Bill, TEA, Time and Extent, Time-and-Extent, GRASE