FDA Webinar on Access to Investigational Drugs

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Updated April 17, 2021

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Training and Continuing Education - Educational resources and training opportunities for healthcare professionals, industry, consumers, and academia - FDA.gov

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The FDA is hosting a webinar where you can learn more about access to investigational drugs. The featured speakers, Theresa Toigo, Director, Office of Special Health Issues and Richard Klein, HIV/AIDS Program Director, Office of Special Health Issues, will discuss what to consider when deciding whether to seek access to an investigational drug and the ways to access investigational drugs. There will be time for questions following the presentation. The 30 minute webinar will be held Tuesday, February 23, at 3 p.m. ET.

You can find out more information about the webinar, including how to participate in the webinar, on the Upcoming Webinar on Access to Investigational Drugs web page.

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Free FDA IND Education For Small Business on Oct 15 2009

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process, CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.

• Agenda (PDF - 64KB)
• Registration form (PDF - 20KB)

Date: October 15, 2009 Time: 8:00 a.m. - 5:00 p.m.

Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102. There is no registration fee Space is limited to 225 participants. The FDA appreciates advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis. 

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New FDA Guidance - cGMP Practice for Phase 1 Investigational Drugs

There was lots of coverage on this recently released FDA guidance, "Guidance for Industry - CGMP for Phase 1 Investigational Drugs. " (PDF) I'm posting the link to this guidance so that it can be easily found and downloaded. Here's what the introduction in the guidance says . . .

• This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.2 These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs).


• Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. This guidance applies, as part of CGMP, quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.


• This guidance replaces the guidance issued in 1991 titled Preparation of Investigational New Drug Products (Human and Animal) (referred to as the 1991 guidance) (Ref. 1) for the manufacture of phase 1 investigational drugs described in this guidance (see section III). However, the 1991 guidance still applies to the manufacture of investigational new products (human and animal) used in phase 2 and phase 3 clinical trials.


• The guidance finalizes the draft guidance entitled "INDs—Approaches to Complying with CGMP During Phase 1" dated January 2006; and is being issued concurrently with a final rule that specifies that 21 CFR part 211 no longer applies for most investigational products (see section III), including certain exploratory products (Ref. 2) that are manufactured for use in phase 1 clinical trials. The agency recommends using the approaches outlined in this guidance for complying with § 501(a)(2)(B) of the FD&C Act.


• FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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FDA Will Exempt Phase 1 Drugs from GMP Regulations

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Good article on FDANews, "FDA Moves Forward With Exempting Phase I Drugs From GMPs." In the article, the agency is cited and says, "FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture.”

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