Science & Technology

29
Jun

Patient Experience Outcomes Still Puzzle FDA Staff and Stakeholders

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 […]

Read More
02
Jun

Don’t Get a Swelled Head, Feeding Tube Guidance Straightens Out Requirements

Today, the FDA released its draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry (here).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 […]

Read More
11
May
Businessman reading long paper list

FDA Posts Eight New Guidances This Morning

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 […]

Read More
30
Apr
Quality Agreements Image

Important ISPE Meeting on Quality Risk Management Sustainability

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 […]

Read More
29
Apr

Day Two of the Generic Drug Forum – Morning Sessions

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 […]

Read More
25
Jan

Compliance/Enforcement Activity, the Slow Down, and Predictions

Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry.  COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry.  High […]

Read More
08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

Read More
12
Aug

Analytical Data Review:  The Thankless Job

In any analytical laboratory that performs cGMP testing, data review is required.  However, to an analytical chemist that prefers benchwork, reviewing the data of a fellow analyst is often deemed an undesirable chore.  The data reviewer rarely gets a “Thank you” for pointing out irregularities in documentation.  The role of the data reviewer is to […]

Read More
22
May

WHY YOUR QUALITY CULTURE MATTERS NOW MORE THAN EVER

Nothing is normal these days.   We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives.  Rules have changed to accommodate circumstances, and expectations have been colored by those changes.  Take for example FDA’s Emergency Use Authorization […]

Read More
14
May

Lachman OnCall™ GMP Teleconsulting for the Life Sciences

Need answers to your urgent life science questions? Lachman Consultant Services, Inc. (Lachman Consultants) has launched Lachman OnCallTM GMP Teleconsulting. It’s your opportunity to speak to our Subject Matter Experts (SMEs) regarding your questions as they occur. Whether you have questions about compliance or a complex scientific or technical issue, we’re here and ready to […]

Read More
1 2 18