Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Forms / CMC Postapproval Manufacturing Changes for Specified Biological Product in Annual Reports / Public Meeting on Benefit-Risk Assessments in Drug Regulatory Decision-Making

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Forms Guidance / CMC Postapproval Manufacturing Changes for Specified Biological Product in Annual Reports Guidance / Public Meeting on Benefit-Risk Assessments in Drug Regulatory Decision-Making

1. Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft Guidance for Industry

FDA is announcing the availability of a revised draft guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. Through this notice, FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety.

2. Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Draft Guidance for Industry

FDA is announcing the availability of a draft guidance for industry entitled “CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.” This draft guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to be documented in annual reports. Specifically, the draft guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that the Agency generally considers to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Under FDA regulations, such minor changes in the product, production process, quality controls, equipment, facilities, or responsible personnel must be documented by applicants in an annual report.

3. Benefit-Risk Assessments in Drug Regulatory Decision-Making; Public Meeting

FDA is announcing a public meeting to convene a discussion of topics related to the structured assessment of benefits and risks in drug regulatory decision-making. This meeting will focus on regulatory and industry experiences with approaches to structured benefit-risk assessments, approaches to incorporating patient perspectives into structured benefit-risk assessment, and exploration of methods to advance structured benefit-risk assessment. The format of the meeting will include a series of presentations on the above topics related to structured assessment of benefits and risks, followed by a discussion on those topics with invited panelists and audience members. This meeting satisfies an FDA commitment that is part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).

The public meeting will be held on September 18, 2017, from 9 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center (the Great Room), Silver Spring, MD 20993-0002.

Registration to attend the meeting must be received by September 11, 2017. Public comments will be accepted through November 18, 2017.