On April 15, 2022, FDA published a Manual of Policy and Procedures (MaPP) that outlines the FDA thinking on what constitutes a complex drug product for purposes of classification. A MaPP, as you know, is not an industry tool, but rather an instruction to FDA staff as to the policy and procedure that they utilize […]
For the first time in two years, a number of Lachman Consultants Team were able to attend the PDA Annual conference in Dallas, Texas this week. At this meeting, there was an opportunity for many of the PDA Interest Groups (IGs) to have face-to-face discussions that had, for the last two years been virtual due […]
The ICH has developed a draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures, both endorsed on March 22, 2022 for public consultation. The draft, along with other ICH guidances on validation and analytical procedures, can be found here. The draft revision of […]
The theme for the PDA annual meeting this year is “Agility in the New Normal.” The plenary address kicked off the meeting with an interesting presentation by Dr. Jeffrey Baker, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), titled “Pandemic Response, Regulatory Rubric, and the Nature of Rubber Bands.” He spoke about the intrinsic […]
Today, the FDA published the eighth revision of a guidance titled Part VI: Impurities: Residual Solvents (Maintenance): PDES For 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tertiary-Butyl Alcohol (here). This revision adds the three residual solvents named above and provides permitted safe daily exposure (PDE) limits for patients. The guidance provides information on the solvents themselves, the […]
In a 33-page report titled Assessment of the Use of Patient Experience Data in Regulatory Decision-Making prepared by Eastern Research Group (here), the views of the FDA and its stakeholders (patients, industry, and physicians) are either leaning towards “we are just figuring it out” (FDA) or “we have no real idea how the Agency utilizes […]
Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here). There have been numerous cases of clogging or otherwise blocking of enteral naso-gastric (N-G) feeding tubes when medication is administered due to a number of different reasons: swelling of […]
Covering a multitude of subjects, the Agency published eight new guidance documents ranging from the ICH M9 BCS classification system to a Q&A document on qualified infectious disease designations. Here is a list of the eight guidance documents. M9 Biopharmaceutics Classification System-Based Biowaivers (here) E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis […]
On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management. Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical […]
Starting at the crack of dawn for us west coasters, today’s meeting kicked off with three presentations on application issues: mid-cycle meeting overview; information to include in cover letters; and application communications – quality perspectives. Lots of information was presented and highlights are discussed below. Mid-cycle reviews are reserved for complex generics and may also […]
