11/01/2019

"Understanding the FDA’s Knowledge-Aided Assessment and Structured Application (KASA) Framework"

Bikash Chatterjee, President & Chief Science Officer

KASA represents an ambitious step forward for the FDA in standardizing and increasing the efficiency of the drug review process. Bikash Chatterjee writes that the challenge will be to set up risk evaluation standards that serve the spectrum of current and future drug therapy programs and leverage industry’s experience in creating and managing these systems.

DOWNLOAD ARTICLE
10/25/2019

"Hurry Up and Wait: Brexit from a Regulatory Point of View Part 2"

Lynn Hansen, Director, Regulatory Affairs

Lynn Hansen talks about strategic contingency plans, in the form of numerous government guidance/instructions developed for “a Brexit deal” or “no Brexit deal.” When the UK’s Medicines and Healthcare Regulatory Agency (MHRA) becomes the UK regulatory authority once again, it may end up obtaining a seat on International Council on Harmonization (ICH).

DOWNLOAD ARTICLE
10/24/2019

"Hurry Up and Wait: Brexit from a Regulatory Point of View"

Lynn Hansen, Director, Regulatory Compliance

Lynn Hansen points out the challenges that stem from Brexit for regulators guiding the transition for pharmaceutical, medical device, biotech, and veterinary companies, and the resources in place to ensure that the supply chain of valuable products for many patient populations can be maintained.

DOWNLOAD ARTICLE
10/15/2019

"Pharma 4.0: Building Quality into Pharma Manufacturing, from Molecule to Medicine"

Bikash Chatterjee, President & Chief Science Officer

Bikash Chatterjee discusses the current and potential impacts of the application of Industry 4.0 concepts to the pharmaceutical manufacturing industry, in an article in Tablets & Capsules, October 2019.

DOWNLOAD ARTICLE
10/14/2019

"Comparing New US & EU Guidances of the Combination Product Approval Process"

Caitlin Bancroft, Regulatory Affairs Associate

Caitlin Bancroft of Pharmatech examines the EU draft guidance for combination products in part 2 of a two-part series in Pharmaceutical Online. Based on the new guidance issued by regulatory bodies for the U.S. and the EU, manufacturers should adjust their timelines for putting products on the market, and read and comment on the guidance.

DOWNLOAD ARTICLE
09/24/2019

"Analyzing FDAs Draft Guidance On Premarket Review Of Combination Products"

Caitlin Bancroft, Regulatory Affairs Associate

Designing Combination products for compliance: Caitlin Bancroft of Pharmatech analyzes the new U.S. draft guidance (part 1) and the EU draft guidance in a two-part article in Pharmaceutical Online. Regulators on both sides of the Atlantic risked falling behind when it comes to combination products that are ever increasing in complexity and capability. New EU draft guidance, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are important. In this two-part series, Caitlin Bancroft examines the two guidances in detail.

DOWNLOAD ARTICLE
07/19/2019

"Regulatory Update: Premarket Notification 510K Class 11 Device"

Caitlin Bancroft, Regulatory Affairs Associate

In an article in Pharmaceutical Outsourcing, Caitlin Bancroft of Pharmatech Associates explores several new upgrades to the 510(k) regulatory pathway implemented by the FDA. The agency’s efforts impact many different aspects of the device approval and monitoring systems, including: pre-market requirements, the use of real world evidence in applications, substantial equivalency determinations, and post-market surveillance. Two particularly impactful changes are the newly established Safety and Performance Based Pathway, and the unofficially proposed 10-year cap on predicate devices.

DOWNLOAD ARTICLE
05/31/2019

"Jump into cGMP: An FDA Roadmap to Manufacturing Tissue-based Products"

Lynn Hansen, Director, Regulatory Affairs

Lynn Hansen, RAC, explores a basic roadmap for the process of migration to the new regulatory environment, within the 36-month timetable mandated by the FDA and ending on November 16, 2020.

DOWNLOAD ARTICLE
05/21/2019

"What Pharma Needs to Understand About Combination Product Development"

Bikash Chatterjee, President & Chief Science Officer

Pharmaceutical Technology spoke with Kerri-Anne Mallet, Clinical and Regulatory Affairs at Pharmatech Associates and with Bikash Chatterjee, Chief Science Officer and president; Lynn Hansen, RAC, director, Regulatory Affairs; and Caitlin Bancroft, Regulatory Affairs; all at Pharmatech Associates, about some of the differences in drug and device development, best practices for combination product development, and issues specific to Internet-connected combination products.

DOWNLOAD ARTICLE
05/14/2019

"Techniques for Risk-based Validation Using ASTM E2500"

Michele Levenson, Senior Program Manager

Michele Levenson of Pharmatech Associates writes about risk-based validation in an expert column in Pharmaceutical Online. Depending on where your organization is on the pendulum of risk tolerance, there are many benefits to adopting risk-based validation (RBV) and ASTM E2500 within an overall validation strategy, as long as the organization is structured appropriately.

DOWNLOAD ARTICLE