FDA GCP - Tips On Conducting non-US Studies

If you're looking to conduct clinical studies outside the U.S., you might do well to read this superb article from Bruce Mackler on GEN, "Spotlight on the FDA Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues. Mackler says, "In today’s financing environment, the absence of early clinical data presents a high barrier to obtaining funding. Investors often say “show me the clinical data that show that the drug is safe and works and I will show you my money.” As a result, biopharma companies have moved into early non-U.S. clinical trials that have lower safety data burdens. These studies are being conducted in less wealthy (a.k.a., developing) countries, where Phase I trials can be more rapid and less costly. This strategy has been promoted by CROs established in these countries." The article provides some great tips, not to be overlooked. 

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Wow - FDA OKs Stem Cell Trial - This is a red letter day!

I'm thrilled to see some momentum gaining in this potentially rich area of clinical research. The U.S. Food and Drug Administration has granted clearance for Geron Corp. to begin trials for the world's first study of a human embryonic stem cell-based therapy for people. Geron said it will begin a Phase I multicenter trial designed to establish the safety of its treatment, currently referred to as "GRNOPC1," in patients with complete Grade A subacute thoracic spinal cord injuries. Read more details in this Medical News Today article, US Approves First Trial Of Embryonic Stem Cells.

I'm of the opinion that stem cell research has been stifled for way too long, and it's good to see the appearance of these studies. What's your opinion?

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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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