Quality Systems

FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, overall approaches.

The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.

Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.

Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.

Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.

Chapter 2.9.40 of the European Pharmacopeia is the binding requirement for dosage uniformity. Recently, an additional alternative chapter 2.9.47 has been created titled "Demonstration of Uniformity of Dosage Units using large Sample Sizes".

The US Pharmacopeia (USP) is examining the issue of uniformity of dosage units to address whether scoring yields consistent split doses. Anthony DeStefano, Ph.D., senior vice-president, general chapters and healthcare quality standards, provides an overview of the USP's work in this area.

Tablet splitting is a new area of focus for regulators. The FDA tells PTE more about the challenges in this area.

The management board of the European Medicines Agency (EMA) has endorsed the agency?s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012.

Mylan issued a voluntary recall of three lots of the painkiller tablets hydrocodone bitartrate and acetaminophen.

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

Malvern Instruments Opens New Applications Laboratory in Brazil; Roche To Invest in Diagnostics Production in Germany; and More.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

FDA releases guidance documents on PET drugs, labeling of OTC sunscreen, and the use of certain phthalates as excipients.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

The company issues voluntary recall of certain lots due to possible contamination with small glass particles.

The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.

As the battle against counterfeits gains momentum, PharmTech speaks to Mark Davison, CEO of Blue Sphere Health, and Craig Stobie, global life sciences sector manager at Domino Printing Sciences, about the challenges involved.

To ensure the accuracy of scientific testing, protect the subjects to avoid data contamination.

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.

Can postapproval FDA filings immunize pharma companies from patent lawsuits?

A change in terminology could emphasize patient protection.

Domestic companies are changing their business models in response to recent drug price cuts.

EMA addresses drug supply shortage.

Overt and covert packaging technologies have evolved to authenticate drugs and fight counterfeits.

FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.

USP announces new drug naming policy and FDA releases two guidance documents.

FDA provides information on its Enhanced Communication Team created in response to PDUFA V.

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.

FDA pushes back goals due to Hurricane Sandy and EMA announces changes to variation regulations.