Boehringer Ingelheim says it will pump a further €330m ($453m) into a German manufacturing facility critised by the US FDA in its rejection of the drug empagliflozin.
The Alliance for a Stronger FDA has expressed disappointment that President Obama’s FY 15 budget request for FDA falls short of what the agency needs to fulfill its responsibilities.
Addiction doctors have petitioned the US FDA to prevent Zohydro ER, the first single-entity hydrocodone painkiller, hitting the market this month citing its potential for abuse. Its maker, Zogenix, has been tight-lipped on whether the drug’s formulation...
The European Medicines Agency (EMA) stressed the potential benefits of continuous process validation in guidance issued this week and underlined that data submitted by drugmakers must demonstrate the adequacy of production operations at each site.
The New Zealand Medicines and Medical Services Safety Authority is looking to update its abbreviated evaluation process, which is intended to be a simpler and quicker process than the standard evaluation process.
Plans to give customs officers the power to seize and destroy suspected fake medicines as they move through the EU have been welcomed by industry group EFPIA.
European regulators have been accused of making “no attempt” to counter misuse of prescription drugs in comparison with North American efforts to reformulate and restrict addictive drugs, according to a Canadian firm testing the abuse potential of medicines.
National prioritization, investments in healthcare infrastructure and building better epidemiological and cost databases could bring more innovative medicines to middle-income countries, according to an independent study conducted by Charles River Associates.
Pharma industry employees and wholesalers with access to narcotic APIs would be subject to background checks and drug testing under new proposals being considered in the US.
In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators.
The US FDA on Monday announced in a draft guidance that it’s revising its historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products.
Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.
Fraudsters who try to extort money by impersonating regulators are an ongoing problem, the US FDA says, after the Gujarat FDCA warns drugmakers about a new scam.
The European Commission (EC) has increased the pressure on Ireland, Italy, Poland and Slovenia to fall into line with other EU member States and introduce anti-drug counterfeiting legislation.
As Commisioner Margaret Hamburg flies back from an eight day tour of India, the US Food and Drug Administration (FDA) says it is recruiting seven new drug investigators in the country.
The US FDA has upgraded Hospira’s troubled Rocky Mount, North Carolina plant to VAI (voluntary action indicated) status though its 2010 Warning Letter still stands.
It is too early to predict what impact proposed changes to US rules on chemical plant security and anti-terrorism measures would have on the drug industry according to PhRMA.
The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.
European drug manufacturers will have to control the critical aspects of their operations through qualification and validation over the lifecycle of the product and process, according to a new draft GMP guideline from the European Commission.
Indian health minister Sh Ghulam Nabi Azad has defended the quality of the country’s drug exports, telling visiting US FDA Commissioner Margaret Hamburg that “affordable” does not mean cheap and spurious.
US drug regulators have claimed recent law changes that enhance communication with pharmaceutical manufacturers helped prevent 140 potential drug shortages in 2013.
US Food and Drug Administration Commissioner Margaret Hamburg will travel to India from February 10-18 to strengthen the agency’s cooperation with Indian regulators at a time when India needs some direction.
CordenPharma has received certification of Potent Compound Safety at a US plant and joins a growing list of drugmakers looking to assure HPAPI safety, according to SafeBridge Consultants.
Daiichi-Sankyo says ensuring API supply could be a problem at Ranbaxy’s US finished product sites after imports are banned from yet another of its Indian facilities.
Increased in-house API production and manufacturing in India will lower the costs of Hospira’s injectables, the firm says, as it looks past current remediation efforts.
Eli Lilly is spending €75m ($102m) to meet latest global anti-counterfeiting regulations, its security experts said in an exclusive interview with in-Pharmatechnologist.com.
European dependence on drugs and APIs made outside the EU is still ‘alarming’ despite recently introduced anti-falsified meds laws according to the European Fine Chemicals Group (EFCG).
The US FDA is positioned to increase drug plant inspections in China after US President Barack Obama signed a $1.1tr (€881bn) budget for fiscal 2014 into law on Saturday.
GMP auditors need a professional qualification similar to QP status according to a group whose new training scheme is designed to create a competency benchmark.
Aurobindo has denied reports of a boiler blast at an Andhra Pradesh, India facility whilst Amgen is investigating an incident at its San Francisco R&D site.
The European Medicines Agency (EMA) has published for the first time details of manufacturers who have violated GMP as part of its transparency initiative.
Reporting rules designed to prevent drug shortages are likely to be similar in Europe and the US according to the industry group that represents European generic drugmakers.
New GMP rules mean Kangtai Biological Products cannot restart production of a Hepatitis B vaccine wrongly linked to deaths even though authorities now deem it to be safe.
Good news for stem cell scientists this week with new data indicating that patients support the use of induced pluripotent stem cells (iPSC) in biopharmaceutical research if proper consent is obtained.
