Development

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Combination Products Raise New Manufacturing Challenges

Shana K. Cyr is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

Paula Miller is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

Deborah M. Herzfeld is an attorney at McNeill Baur PLLC.

Robert F. Shaffer is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

The authors discuss regulatory and patent issues with combination products.

Combination Products: Regulatory and Patent Issues You Should Consider Now

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

Navigating the Regulatory Landscape of Combination Products

Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.

Tackling challenges in the development of fixed-dose combinations

Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes. Results showed that BioChaperone Combo provided both short- and long-term control of blood glucose in type I diabetic patients, with a faster onset and a longer duration of action.

Adocia's Combination Insulin Formulation Shows Positive Results in Phase I/II Trial

Researchers at Massachusetts recently reported on the development of a drug-eluting contact lens designed to provide prolonged delivery of the glaucoma medication, latanoprost.

Contact Lens For Prolonged Delivery of Glaucoma Medication

Sean Milmo is a freelance writer based in Essex, UK.

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

Seeking Harmonization in Nanomedicines Regulatory Framework

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Should Regulation of Combination Products Become More Centralized in Europe?

Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.

A Hybrid Approach to Combination Products

To find out about the regulatory, formulation, and manufacturing considerations involved in developing a new device to deliver a drug, Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.

Formulation and Drug Delivery, Combination Drugs