News

Marketed Unapproved Drugs

PDG — Wed, 23 May 2012 20:35:44 +0000

FDA has long held the position that they are subject to take aggressive action against companies that market drugs they consider unapproved. FDA’s most recent notice to industry stated that “any unapproved new drug introduced onto the market after September 19, 2011 will be subject to immediate enforcement action, without prior notice and without regard to the enforcement priorities set out in CPG 440.100.” The Guidance notes that actions which FDA may take against such firms, “would typically involve one or more of the following: requesting voluntary compliance; providing notice of action in a Federal Register notice; issuing an untitled letter; issuing a Warning Letter; or initiating a seizure, injunction, or other proceeding.” PDG routinely assists companies in their responses to FDA actions and regulatory submissions such as 505(b)(2) NDAs. Contact us for more information.

Nanotechnology and FDA Regulation

PDG — Tue, 22 May 2012 21:32:13 +0000

Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated products, including medical products, foods and cosmetics. Nanomaterials, developed using nanotechnology, are measured in nanometers, -- equal to about one-billionth of a meter -- so small that they can’t be seen with a regular microscope. These nanomaterials can have different chemical, physical, or biological properties than their conventionally-scaled counterpart materials used in many products regulated by FDA.

Contact PDG to find out how we can help your company to safely implement nanotechnology into your FDA-regulated products and production processes.

FDA Risk Evaluation Workshop announced

PDG — Mon, 21 May 2012 21:20:24 +0000

The Food and Drug Administration (FDA) announced a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.” The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved REMS. As labeling experts, PDG can help you decide if a REMS is necessary OR address FDA requirements that you implement a REMS for your drug product.

Risk Evaluation and Mitigation Strategy Assessments Issue Paper

PDG to Attend RAPS Florida Chapter Meeting

PDG — Fri, 18 May 2012 23:11:22 +0000

Those of you who will be in central Florida this week are welcome to join PDG at an FDA presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug Administration (FDA), FLA-DO/TMP-RP entitled “FDA Perspective on Advertising and Promotional Compliance and Social Media” on May 24th, 2012, 5:30–8:30 pm at the Hampton Inn and Suites, Clearwater, FL. The professionals at PDG are here to help your drug or device company address compliance issues relating to advertising and promotional labeling and interface with The Office of Prescription Drug Promotion (OPDP; formerly Division of Drug Marketing, Advertising and Communications - DDMAC). Feel free to contact us for OPDP consulting. According to RAPS, "The US Food and Drug Administration (FDA) has developed a series of regulations governing advertising and promotion. These regulations, designed to promote public safety and understanding about healthcare products, are not always easy to interpret and follow, particularly with today’s new social media. The FDA presenter at this event will provide perspective on these regulations and will discuss not just what FDA is doing, but also what the agency might do in the future.”

Prescription to OTC: PDG Attends FDA Public Hearing on Expanded Access to Nonprescription Drugs

PDG — Fri, 13 Apr 2012 14:24:03 +0000

The agency held a public hearing on March 22-23, 2012 to “obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use.” The hearing was preliminary with no new rules passed. However, PDG’s Director of Regulatory Affairs noted that the hearing seemed to invite new approaches to current and future Rx to OTC 505(b)(2) submissions. PDG plans to update this posting with a transcript of the proceedings as soon as they are published. Meanwhile, please feel free to contact us if your company would like to learn more about Prescription to OTC switches.

http://www.fda.gov/Drugs/NewsEvents/ucm289290.htm

PDG to attend FDA's OTC Public Hearing

PDG — Mon, 12 Mar 2012 22:26:24 +0000

The agency recently announced a public hearing to “obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use.” Please let us know if you plan to attend so that we can meet you over dinner on Thursday night. The meeting dates and times follow:
                   10903 New Hampshire Avenue
                   Bldg. 31, Room 1503
                   Silver Spring, Maryland 20993

Date: March 22-23, 2012

Time: 9:00 a.m. to 4:00 p.m.

Location: FDA White Oak Campus

10903 New Hampshire Avenue
Bldg. 31, Room 1503
Silver Spring, Maryland 20993

http://www.fda.gov/Drugs/NewsEvents/ucm289290.htm

Federal Register Notice

Webcast of Meeting: The webcast can be accessed via the following web link: https://collaboration.fda.gov/march2012part15/

PDG to Attend RAPS Florida Chapter Launch Meeting

PDG — Mon, 06 Feb 2012 15:18:00 +0000

The Regulatory Affairs Professionals Society (RAPS) has announced that several regulatory professionals in Florida are interested in launching a RAPS Chapter. PDG is pleased to inform our readers that we will be joining RAPS for the inaugural meeting to interact with other regulatory professionals from our area. The meeting will be held in Tampa on February 15, 2012 from 5PM to 7PM. If you would like to join us or learn more about how PDG can help you with your FDA consulting needs, please click here.

Regulatory Affairs Updates: Latest on ANDA User Fees (GDUFA)

PDG — Tue, 24 Jan 2012 22:06:31 +0000

FDA and industry leaders have agreed on legislation that, if passed by Congress, will usher in user fees for ANDA sponsors. As currently drafted, a one-time backlog fee is anticipated for “Each person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date”. The draft legislation notes that the backlog fee will be computed by dividing the total number of applicable ANDAs into $50 million. As of December 2011 the backlog consisted of approximately 2,500 applications, though not all could be considered “applicable”. Once the backlog fee is calculated, the amount will be announced in the Federal Register. Click here for help with your ANDA, 505(b)(2) or NDA submission and other FDA consulting needs. Click on the following links to learn more about GDUFA:

Time and Extent Applications for Nonprescription Drug Products (OTC) Guidance Introduced

PDG — Tue, 04 Oct 2011 14:57:42 +0000

According to FDA, "This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-thecounter (OTC) drug monograph system and to describe the process for submitting that information. FDA regulations set forth criteria and procedures by which OTC drugs that initially were marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system (21 CFR 330.14)." Contact PDG to learn more about how this may affect your introduction of OTCs into the market given the latest Guidance on unapproved drugs.

Unapproved Drug Enforcement Policy Revised by FDA

PDG — Tue, 20 Sep 2011 14:25:53 +0000

On September 19, 2011, FDA published a Notice to Industry announcing its revised Guidance for Marketed Unapproved Drugs – Compliance Policy Guide, replacing the version previously released in June 2006. This guidance represents a shift in FDA's approach to enforcement actions related to marketed drugs without approved NDAs, ANDAs or OTC monograph compliance. To learn how PDG can help you ensure compliance with this, or other FDA mandates, contact us now.