07-Mar-2013 - A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.
07-Mar-2013 - A new partnership between a niche cancer drug discovery company and biotech powerhouse Celgene could pave the way for the future of cancer drug discovery and delivery.
06-Mar-2013 - Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.
05-Mar-2013 - Chinese regulators want to improve how drugs are developed, reviewed and distributed in the country.
04-Mar-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
28-Feb-2013 - The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.
28-Feb-2013 - Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time in critical pre-IND/BLA meetings.
27-Feb-2013 - As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.
26-Feb-2013 - US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.
25-Feb-2013 - The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.
25-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
21-Feb-2013 - European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.
21-Feb-2013 - Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas.
18-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
14-Feb-2013 - Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.
13-Feb-2013 - Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).
11-Feb-2013 - Sun Pharmaceutical Industries has abandoned its long running efforts to buy Israel’s Taro, explaining the move is in the best interest of shareholders.
11-Feb-2013 - The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation on the photosafety testing of drug compounds.
08-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
07-Feb-2013 - In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company downplayed the impact of the letter and said it won’t create any shortages for its US insulin supplies.
06-Feb-2013 - The SFDA wants to forge closer ties with regulators in Switzerland, to date the only country granted exemption from new EU API import laws.
06-Feb-2013 - The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will tweak or overhaul their quality systems and which suppliers of products will need to comply, an expert says.
05-Feb-2013 - CMOs and CROs must notify sponsors of payments made to physicians on their behalf under long-awaited US 'Sunshine' rules published last week.
05-Feb-2013 - The US pharma industry in 2012 saw the lowest number of reported cargo thefts and the lowest average value per incident since the data collection began in 1996.
04-Feb-2013 - Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).
Dispatches from Excipient Fest in Baltimore - UPDATE
As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and...
Dispatches from Excipient Fest in Baltimore
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Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax...
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020...