Compliance

09
Feb

As Ibuprofen Shortage Rages On, FDA Revises Recently Issued Guidance

On February 9, 2023, the FDA issued a revised guidance (here) on the compounding of Ibuprofen oral suspension products for outsourcing facilities.  We previously posted about the original document (here) and discussed the basic factors that caused the Agency to issue the guidance without public comment to meet the needs of a drug shortage that […]

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26
Jan

Breaking News – CBD Now Four Square on FDA’s Regulatory Radar and Agenda

After initial publication, this post was updated to provide links to the three petitions that FDA denied as mentioned above. https://www.regulations.gov/document/FDA-2020-P-1582-0005 https://www.regulations.gov/document/FDA-2022-P-0600-0005 https://www.regulations.gov/document/FDA-2019-P-5394-0004   The FDA has been struggling with the issue of CBD for quite a while. The use of CBD products in the marketplace has surged with CBD being claimed to be a […]

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24
Jan

Investigations and Third Parties – Beware!

ICH Q10 (here) states the following as it relates to outsourcing activities and purchasing materials (hereafter referred to as third party): “The pharmaceutical quality system, including the management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately responsible to […]

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23
Jan

FDA Guidance for Compounding Ibuprofen Suspension is in Effect Immediately!

With the United States currently experiencing shortages of Ibuprofen suspension due to an increased demand that the FDA states is caused by “a surge in three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza,” the Agency recognizes the need to establish an appropriate enforcement strategy to aid in the availability of this […]

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13
Jan

Dear World, Ethylene Glycol Is Not a Sweetener and Is Poisonous Even as a Contaminant!

The Food, Drug, and Cosmetic Act of 1938 was precipitated by a disaster where over 100 people died, many of whom were children.  In the early 1930s, a wonder drug called sulfanilamide was marketed for treatment of certain infections.  The problem with the drug was that it was very bitter, and, because of this, children […]

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10
Jan

Failure of Congress to Take Action on Dietary Supplements Keeps Status Quo

Seemingly every day, there is news of a dietary supplement (DS) running afoul of regulations, either by containing a hidden drug ingredient or claiming the product is used in the cure, mitigation, or treatment of a disease, running afoul of the existing FDA dietary supplement regulations.  Congress had the opportunity to redefine FDA oversight of […]

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23
Dec

Analytical Method Validation, Verification, or Qualification – What to use and when?

Analytical development and/or QC groups at early-stage pharmaceuticals and biopharmaceuticals often ask themselves about the level of level of confirmation of suitability required for their methods. Often the term ‘validation’ is used without understanding the full implications of the term. Sometimes, the terms validation, qualification and verification are used interchangeably. While ‘validation’ is well understood […]

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14
Dec
Data Analysis for Business and Finance Concept

Digitization and Future Highlighted at the ISPE Pharma 4.0 and Annex 1 Conference

The 2022 ISPE Pharma 4.0 and Annex 1 Conference, which just concluded in Vienna, Austria, highlighted the exploding value of digitization in pharmaceutical aseptic manufacturing and quality, and how digitization will play a key role in the attainment of sustainable and robust compliance for the new revision of EU GMP Annex 1 for manufacture of […]

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08
Dec

FDA Proposes Rule to Change the IND Annual Report

Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing […]

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