Tech Talk

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.

Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.

As more patents make their way through IPRs, the balance of how the pharmaceutical industry selects between IPRs and district court litigation will likely evolve.

A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.

Important research is under way that will help us understand the extent of the presence of substandard, adulterated and counterfeit drugs around the world, and, thus, strengthen enforcement efforts and public outreach programs. Future studies will focus on the API and overall chemical content

A recent Ernst & Young survey highlights the challenges facing Indian pharma

As public criticism of drug prices intensifies, and healthcare moves to "value-based" pricing and purchasing, Sloan-Kettering’s interactive, online tool Abacus offers insights into the factors that must go into pricing a drug

Experts at Eppendorf discuss common challenges in cell culture and share insights on possible solutions.

With drug development trends shifting towards personalized medicines, new technologies are needed for the manufacture of these highly sensitive drug products.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

Peer-reviewed papers and technical articles can help advance bio/pharmaceutical development.

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.

As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.

The basic principle behind QbD is that quality should be built into a product with an understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks.

The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.

With the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.

As a special session at Interphex 2015 this week made clear, few pharma companies are ready for serialization and aggregation deadlines. The disconnect between pharmaceutical manufacturers and their contract partners poses a special risk.

The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?

The growing threat and spread of antimicrobial resistance continue to ring alarm bells worldwide.

CPhI report notes that the Indonesian pharma market is on the brink of a regional manufacturing boom, with market capitalizations and company values rising.

FDA approves a biosimilar and loses a commissioner in March.

Statistics presented in a March webinar suggest a strong, but highly fragmented, small-molecule API market