The Australian Government has announced a plan to improve how the TGA communicates with stakeholders just days after criticism about plans to increase fees.
So far only Switzerland and Israel have asked to be included in the list of countries not required to provide written confirmation that plants making APIs destined for the EU meet the required standards according to an EC statement.
An insomnia treatment linked to sleepwalking and sleep driving should stay on the market according to the Australian Therapeutic Good Administration (TGA).
The US FDA has published a 483 detailing the violations it observed during an inspection of stem cell firm Celltex Therapeutics in April and the document does not make for comfortable reading.
The implementation of single use technology in the biopharmaceutical fill and finish process has seen a massive uptick recently because of better industry understanding, according to Pall’s Bruce Rawlings.
Scientists have uncovered a new simple way to “clean” genotoxic impurities (GTIs) in drug ingredients by mixing the solution with contamination-eating scavengers.
PPMA is fearful that the Government of Pakistan’s recent call for more foreign investment in the local pharma sector will go unheard because the industry is already overcrowded.
New 'similar biologics' guidelines will curb the rising cost of innovation, attract overseas investment and ensure patients have access to drugs according to the Indian Government team which launched them at BIO 2012.
Submitting a REMS (Risk Evaluation and Mitigation Strategies) proposal for risky drug developments could earn companies brownie points, according to Quintiles’ Ed Tabor.
German drug approval and pricing laws are prompting Pharmas to abandon the market says the EFPIA, which has called for ‘urgent action’ to protect innovation and access to medicines.
The US drug industry has welcomed news that Senate has passed the FDA’s amended User Fee Reauthorization Bill in the hopes it will mean a safer global supply chain.
The US FDA has issued a warning about Hospira’s Carpuject prefilled cartridges after batches were found containing more than twice the amount of recommended dosage.
The US FDA will have more powers to inspect ‘risky’ overseas pharmaceutical plants according to supporters of a bill being considered by the US senate this week.
