June 12, 2003   

No. 12-03   

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CHPA joins forces with PDFA and AAP in the war against methamphetamine
The Association participated in a June 10 press conference in St. Louis to launch a two-year educational campaign to teach parents and teens the dangers of drug abuse.

CHPA's ELF® has arrived!

Members can now use CHPA's new member service―the ELF®―that provides access to important government agency materials.

FDA and industry will provide the ABCs of cGMPs at joint summer workshops

The first FDA/industry summer workshop of current Good Manufacturing Practices (cGMPs) will debut June 16 in East Rutherford, New Jersey.

Only a few spots left for CHPA MarkePlace 2003 Business Exchange

Interested members only have a few weeks left to reserve a tables for CHPA MarketPlace 2003 Business Exchange.

CHPA supports bar code concept, but seeks further clarification for OTCs

In June 11 comments to FDA on bar codes, CHPA asks the Agency to clarify an narrow which OTC products it intends to include.

FDA published two final OTC drug monographs

FDA recently published two final monographs for OTC drugs, one for skin protectants and the other for antiperspirants.

NDAC votes on ipecac
At a June 12 meeting of FDA's Nonprescription Drugs Advisory Committee, members recommended that syrup of ipecac's OTC status be discontinued.

FDA allows more time to relabel USP names

Companies now have until September 1 to bring certain OTC suncreen product labels into compliance with five new United Stated Pharmacoepia ingredient names.

Comment period reopened for proposed amendment to internal analgesic tentative final monograph
FDA has granted a 90-day extension for comments on its proposed rule that would amend the tentative final monograph for OTC internal analgesic.

New legislation would add Rx drug benefit to Medicate program
New bill introduced in the Senate Finance Committee would authorize $400 billion over 10 years to add the prescription drug benefit to the Medicare program.

Several measures pass the litmus test in the House this week

The U.S. House of Representatives passed bills on antitrust and class action lawsuits and approved the reauthorization of the Office of National Drug Control Policy.

House subcommittee investigates bogus dietary supplement

The House Government Reform Subcommittee on Oversight and Investigations issued a subpoena in connection with its investigation into a dietary supplement weight loss product for children.

EU Council of Ministers reaches political agreement on pharmaceutical legislation

The European Union (EU) health ministers reached a political agreement on European Commission proposals on pharmaceutical legislation June 2.

AESGP meeting looks at 'innovating self-care'

CHPA staff were among the attendees at the Association of the European Self-Medication Industry's (AESGP's) annual meeting June 4-6 in France.

FDA to hold prep meeting for ICH and ICH6
A public meeting has been scheduled by FDA in preparation for the International Conference on Harmonisation (ICH) meeting in Belgium and the ICH 6 conference in Japan.

FDA is seeking individuals to represent industry on CDER advisory committees
FDA is currently accepting nomination for nonvoting industry representatives to serve on public advisory committees for its Center for Drug Evaluation and Research.

CFSAN seeks input for FY '04 program priorities
FDA's Center for Food Safety and Applied Nutrition (CFSAN) is requesting input to help develop its 2004 work plan.

Staff travel inside the Beltway and beyond

IPEC-Americas conference to examine marketability of excipients

NBJ summit to convene in San Diego

Click here to view the Calendar of Events.
Editor: Donna Edenhart Click here if you no longer wish to receive this publication.
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Copyright 2003 by the Consumer Healthcare Products Association (CHPA). CHPA's Executive Newsletter is for general information purposes only. Information reported in this newsletter is compiled from various sources. All efforts are made to assure the accuracy of the content, but CHPA cannot guarantee the information.