Regs & Legs

EU measures in support of generic pharmaceuticals producers

21 February 2019 | By European Pharmaceutical Review

The EU is adopting new rules which should boost the competitiveness of EU producers of generic medicines and biosimilar products...

Whitepaper: Head-to-head comparison of hydrogen peroxide and steam sterilisation

21 February 2019 | By Telstar

The pharmaceutical industry is increasingly using different sterilisation technologies rather thansteam sterilisation. This increase is driven by the need for sterilizing thermo-labile products orareas that cannot be dimensioned as a pressure vessel (barrier systems such as Closed Restricted Access Areas or Isolators), under “softer” conditions.

Inadequate FDA oversight concerning fentanyl prescriptions

19 February 2019 | By European Pharmaceutical Review

A study has found that the FDA failed to design and implement an effective monitoring program for Transmucosal Immediate-Release Fentanyls...

Policy to improve access and foster price competition for generics

18 February 2019 | By Iqra Farooq (European Pharmaceutical Review)

A policy has been implemented to aid companies in the formulation, production and manufacture of generic drugs, especially when the originals are expensive...

Draft guidance on CDER’s program to recognise standards in pharmaceutical quality

14 February 2019 | By European Pharmaceutical Review

Draft guidance has been released to offer advice on the new CDER program for the recognition of voluntary consensus standards relating to pharma quality...

Programs to promote innovations in drug manufacturing

13 February 2019 | By European Pharmaceutical Review

Innovations in drug manufacturing could result in higher quality drugs at less of the cost, and the FDA is willing to help facilitate this development...

Health Canada issues NOC/c for oral myeloid leukaemia therapy

12 February 2019 | By European Pharmaceutical Review

Health Canada has issued a Notice of Compliance with conditions for the first oral drug for acute myeloid leukaemia, a rapidly progressing condition...

Telstar

FDA launches pilot programme to track and trace US supply chain

8 February 2019 | By Nikki Withers (European Pharmaceutical Review)

The pilot project will test innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the US...

PDA Italy Chapter has chosen the new COO of PQE Group, Claudio Puglisi, as member of the executive committee for the role of Chapter Liaison and External Relationship

6 February 2019 | By PQE Group

The counting of votes that saw the election of Mr. Claudio Puglisi, new COO of PQE Group, was held last January 31st in Milan, Italy...

Pricing dispute over cystic fibrosis drug Orkambi continues in the UK

5 February 2019 | By Nikki Withers (European Pharmaceutical Review)

Campaigners call for UK Government to intervene on pricing dispute over cystic fibrosis drug Orkambi...

Efforts to advance the development of complex generic drugs

4 February 2019 | By European Pharmaceutical Review

The FDA has issued a statement to promote the development of complex generic drugs to ensure access for patients and healthy drug competition...

Committee demands answers on rising cost of insulin in the US

1 February 2019 | By Nikki Withers (European Pharmaceutical Review)

Letters have been sent to Eli Lilly, Novo Nordisk and Sanofi asking them to explain the rapidly increasing cost of insulin...

Public consultation on key principles for ePI of EU medicines

1 February 2019 | By European Pharmaceutical Review

The European Medicine Agency has launched a six month consultation on the principles that will form the basis of the electronic product information (ePI)...

Ideal for single-use purification processes and high volume fluid transfer

29 January 2019 | By AdvantaPure

New from AdvantaPure is AdvantaSil High Pressure unreinforced silicone tubing, a high quality, cost effective solution designed to deliver increased flow rates and reduce processing time...