Search Results for

Filtering on: "topics drugs over the counter drugs"

Showing 1 – 25  of 48

Regulatory Strategies for OTC Switch Programs, Implementing EU MDR & IVDR and a Preview of January By Gloria Hall - Published 22 December 2017

Feature articles over the past several weeks provided background, approaches, regulatory considerations, and strategies for implementing prescription to Over-the-Counter (Rx-to-OTC) switch programs; CE marking requirements of IVD medical devices under the new EU regulation; explanation of Annex I general requirements and essential requirements; implementation strategies for the new EU medical devices regulations; and medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes in India.

Categories: Features, India, Europe, US, Clinical, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices

Tags: Feature Editorial

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

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

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

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

FDA Warns Korean OTC Drugmaker Using Noncompliant Contract Manufacturer By Zachary Brennan - Published 12 December 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Seoul, South Korea-based over-the-counter (OTC) drug manufacturer Seindni Co. for current good manufacturing practice (CGMP) violations and labeling concerns.

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

Tags: Coko Loko, Legal Lean Syrup, Seindni

Woodcock: CDER Informatics System is Top Priority for 2018 By Michael Mezher - Published 05 December 2017

Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Generic drugs, Over the counter drugs, Prescription drugs, Submission and registration

Tags: 21st Century Cures, Informatics, CDER

FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included By Zachary Brennan - Published 06 November 2017

The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday.

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

Tags: aspirin, FDA label, cardiovascular images

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