News from the FDA

Last month, the FDA sent warning letters to 16 dietary supplement distributors that were making false and misleading claims for weight loss products promoted over the Internet. Many of these products claim to block starch, carbohydrates and fat calories, while allowing consumers to lose weight without any changes in lifestyle. The FDA found no scientific evidence of these claims. Some of the products affected were InShape Dreamshape, by Better Bodz; F Block Chitosan, by eVitamins.com; and Liposin, by Metabolic Nutrition Inc.

'Solutions to Regulatory Challenges'

The FDA will hold its seventh annual educational conference, “Solutions to Regulatory Challenges,” co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA) of Orange County, CA. The conference is intended to provide the drug, device, and biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the FDA's centers and district offices, as well as other industry experts. The main focus of the conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive question-and-answer and workshop sessions will be included.

The conference will be held June 2 and 3, from 7:30 a.m. to 5 p.m. at The Irvine Marriott, 18000 Von Karman Ave., Irvine, CA. Contact: Ramlah Moussa, Office of Regulatory Affairs (HFR-PA200), Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949-608-4408, FAX: 949-608-4456, or Orange County Regulatory Affairs Discussion Group, Attention to Detail, 5319 University Drive, Suite 641, Irvine, CA 92612, 949-387-9046, Fax: 949-387-9047, Web site: http://www.ocra-dg.org.

Premarket Submission Exemption Terminated for Certain Reprocessed SUDs

The FDA is publishing a list of semicritical reprocessed single-use devices (SUDs) whose exemption from premarket submission is being terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a premarket notification (510(k)). The FDA is requiring submission of these data to ensure that these reprocessed SUDs are substantially equivalent to predicate devices, in accordance with MDUFMA. Manufacturers of reprocessed SUDs identified in the list whose exemptions are being terminated must submit 510(k)s for these devices by July 13, 2005, or these devices may no longer be legally marketed. For more information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-8307.htm.

ICH Draft Guidance on E2E Pharmacovigilance Planning

A draft guidance intended to foster better and earlier planning of pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug, has been issued by the FDA in conjunction with the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH's aim is to bring more uniformity to technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The guidance, titled “E2D Pharmacovigilance Planning,” proposes a structure for a pharmacovigilance plan and sets out principles of good practice for the design and conduct of observational studies. It is available at www.fda.gov/ohrms/dockets/default.htm, www.fda.gov/cder/guidance/index.htm, or www.fda.gov/cber/publications.htm.

Guidance Issued on Changes to Approved NDAs and ANDAs

A revised guidance for industry, titled “Changes to an Approved NDA or ANDA,” is available. This guidance will assist applicants in determining how they should report changes to an approved new drug application (NDA) or an abbreviated new drug application (ANDA). Copies of this guidance are available on the Internet at www.fda.gov/cder/guidance /index.htm.

Content Labeling Requirements Changed for Certain OTC Drug Ingredients

New rules were published on March 24 requiring content labeling (amount present per dosage unit, eg, tablet) and warning labeling for over-the-counter drugs that contain levels of calcium, magnesium, sodium, or potassium that might be harmful to people with certain underlying medical conditions. Mouth rinses, fluoride toothpastes and mouth washes are not covered by this regulation. Under the new rules, the labeling of oral OTC drugs containing sodium, calcium, magnesium or potassium must state the amount of a particular ingredient in each dose if they contain: 1) 5 mg or more of sodium in a single dose; 2) 20 mg or more of calcium in a single dose; 3) 8 mg or more of magnesium in a single dose; or 4) 5 mg or more of potassium in a single dose. The new rules also require new warnings on the label to alert people with kidney stones, decreased kidney function due to kidney disease, or people who are on sodium-, calcium-, magnesium-, or potassium-restricted diets to consult their doctors before using products for oral ingestion that contain more than: 1) 140 mg of sodium as the maximum daily dose; 2) 3.2 grams of calcium as the maximum daily dose; 3) 600 mg of magnesium as the maximum daily dose; or 4) 975 mg potassium as the maximum daily dose. The effective date of these rules was April 23.

Warning Letters Sent over False Weight-Loss Claims

Last month, the FDA sent warning letters to 16 dietary supplement distributors that were making false and misleading claims for weight loss products promoted over the Internet. Many of these products claim to block starch, carbohydrates and fat calories, while allowing consumers to lose weight without any changes in lifestyle. The FDA found no scientific evidence of these claims. Some of the products affected were InShape Dreamshape, by Better Bodz; F Block Chitosan, by eVitamins.com; and Liposin, by Metabolic Nutrition Inc.

'Solutions to Regulatory Challenges'

The FDA will hold its seventh annual educational conference, “Solutions to Regulatory Challenges,” co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA) of Orange County, CA. The conference is intended to provide the drug, device, and biologics industries with an opportunity to interact with FDA reviewers and compliance officers from the FDA's centers and district offices, as well as other industry experts. The main focus of the conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive question-and-answer and workshop sessions will be included.

The conference will be held June 2 and 3, from 7:30 a.m. to 5 p.m. at The Irvine Marriott, 18000 Von Karman Ave., Irvine, CA. Contact: Ramlah Moussa, Office of Regulatory Affairs (HFR-PA200), Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, 949-608-4408, FAX: 949-608-4456, or Orange County Regulatory Affairs Discussion Group, Attention to Detail, 5319 University Drive, Suite 641, Irvine, CA 92612, 949-387-9046, Fax: 949-387-9047, Web site: http://www.ocra-dg.org.

Premarket Submission Exemption Terminated for Certain Reprocessed SUDs

The FDA is publishing a list of semicritical reprocessed single-use devices (SUDs) whose exemption from premarket submission is being terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a premarket notification (510(k)). The FDA is requiring submission of these data to ensure that these reprocessed SUDs are substantially equivalent to predicate devices, in accordance with MDUFMA. Manufacturers of reprocessed SUDs identified in the list whose exemptions are being terminated must submit 510(k)s for these devices by July 13, 2005, or these devices may no longer be legally marketed. For more information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-8307.htm.

ICH Draft Guidance on E2E Pharmacovigilance Planning

A draft guidance intended to foster better and earlier planning of pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug, has been issued by the FDA in conjunction with the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH's aim is to bring more uniformity to technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The guidance, titled “E2D Pharmacovigilance Planning,” proposes a structure for a pharmacovigilance plan and sets out principles of good practice for the design and conduct of observational studies. It is available at www.fda.gov/ohrms/dockets/default.htm, www.fda.gov/cder/guidance/index.htm, or www.fda.gov/cber/publications.htm.

Guidance Issued on Changes to Approved NDAs and ANDAs

A revised guidance for industry, titled “Changes to an Approved NDA or ANDA,” is available. This guidance will assist applicants in determining how they should report changes to an approved new drug application (NDA) or an abbreviated new drug application (ANDA). Copies of this guidance are available on the Internet at www.fda.gov/cder/guidance /index.htm.