Search Results for OTC

Showing 1 – 25  of 54

FDA Bars Use of 24 Ingredients in Antiseptic Washes By Michael Mezher - Published 19 December 2017

The US Food and Drug Administration (FDA) on Tuesday finalized a rule barring the use of 24 active ingredients, including triclosan, from use in over-the-counter (OTC) antiseptic washes and rubs such as hand washes and surgical hand scrubs used in health care settings.

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

Tags: Antiseptics, OTC, Final Rule, Triclosan

Marketing Exclusivity for Over-the-Counter Switched Products By Deborah Livornese - Published 19 December 2017

This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation.

Categories: Features, FDA, Over the counter drugs, Prescription drugs

Tags: OTC Switch, Marketing Exclusivity

Overview of the US Rx-to-OTC Switch Process By Wanda Azu Owoh - Published 19 December 2017

This article provides an overview of the US prescription (Rx) to Over-the-Counter (OTC) switch process, including full switch and partial switch, speaks to the importance of self-care for consumers, and discusses potential areas of opportunity for sponsors and/or industry.

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

Tags: OTC, OTC Switch

The Challenges and Strategies for Today's Rx-to-OTC Switch Programs By Julie Aker, MT(ASCP) - Published 13 December 2017

This article presents the background, approaches and regulatory considerations for prescription to Over-the-Counter (Rx-to-OTC) switch programs. The US Food and Drug Administration (FDA) has conservative expectations for the studies supporting a switch in terms of methodologies and sample sizes. Because of this, other countries will sometimes give consideration of consumer studies conducted in foreign countries on a case-by-case basis, in place of studies conducted in the local country.

Categories: Features, US, FDA, Over the counter drugs, Prescription drugs

Tags: OTC, OTC Switch

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 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

House Committee Considers Four Device Bills to Add to User Fee Reauthorization By Zachary Brennan - Published 02 May 2017

The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: medical device inspections, FDA inspections, hearing aids, OTC hearing aids, MITA, AdvaMed, contrast agents

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

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

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

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

FDA Considers New User Fee Program for OTC Drugs By Zachary Brennan - Published 10 May 2016

The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Government affairs

Tags: OTC monograph, FDA user fee programs, decongestants, over the counter cough medicines

Transparency: What FDA Drug, Device Regulations are Coming Later in 2016 By Zachary Brennan - Published 28 March 2016

As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Compliance, Drugs, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: FDA rules, FDA proposed rules, postmarketing studies of combo products, device labels, compounding drugs, OTC cold medicines

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

Proposed Rule Would Revise Regulations on Fixed-Combination Drugs By Zachary Brennan - Published 22 December 2015

The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and co-packaged drugs, as well as to combinations of over-the-counter active ingredients.

Categories: Biologics and biotechnology, Business Skills, Clinical, Combination products, Compliance, Drugs, Ethics, Government affairs, Labeling, Orphan products, Packaging, Preclinical, Project management, Regulatory strategy, Submission and registration

Tags: fixed-combination drugs, FDA rulemaking, proposed FDA rule, OTC drug monographs, nonprescription drug combinations

FDA Amends Liver Warning Labeling Guidance for Some OTC Drugs Containing Acetaminophen By Zachary Brennan - Published 16 November 2015

The US Food and Drug Administration (FDA) on Monday unveiled amended guidance on the liver warnings that must be contained in labels of over-the-counter (OTC) drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours.

Categories: News, US, FDA, Drugs, Government affairs, Labeling, Packaging, Regulatory intelligence, Regulatory strategy

Tags: Acetaminophen, Tylenol, liver warning, liver damage, OTC, FDA labeling guidance

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

After Intense Scrutiny, FDA Set to Take Another Look at OTC Antiseptics By Alexander Gaffney, RAC - Published 28 July 2014

The US Food and Drug Administration (FDA) will soon hold a meeting regarding the safety and efficacy of non-prescription antiseptic products, just months after raising concerns about the products to manufacturers.

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

Tags: NDAC, Antiseptic, OTC, AdComm, Nonprescription Drug Advisory Committee

Ireland Considers Switching 12 Medicines to OTC Status By Louise Zornoza, RegLink - Published 18 July 2014

Ireland's Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it believes could safely be made available to consumers over-the-counter (OTC).

Categories: News, Europe, Over the counter drugs

Tags: Ireland, OTC, Over-the-Counter, Rx-to-OTC Switch

TGA Proposes Warnings for OTC Oral Cough Medicines and Nasal Decongestants By Louise Zornoza, RegLink - Published 31 March 2014

Categories: Regulatory Update, TGA

Tags: Nasal Decongestants, Cough Medicines, OTC, australia

As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA By Alexander Gaffney, RAC - Published 28 March 2014

Categories: US, FDA

Tags: 503(b)(1), Prescription Drug, Alli, Drug Quality and Security Act, DQSA, OTC, GSK, Track and Trace, Latest News, pharmaceutical, drug