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regulatory

Latest Headlines

Latest Headlines

U.S. FDA plans to double drug inspectors in India as marketing applications soar

The U.S. FDA is hiring new inspectors in India to tackle the high rate of marketing applications made by local firms, an agency official said.

Amid new drug negotiations, China puts price-management vet in charge of CFDA

SINGAPORE-- A change in leadership at the China Drug and Food Administration was announced on the Communist Party website last week: Bi Jingquan, who has more than 20 years of experience in pricing and management, will take over from Zhang Yong as CFDA minister.

India opens medical device industry to foreign direct investment

India's medical device industry will officially open Jan. 21 to unlimited foreign direct investment as the government kicks off what is expected to be a year of vast changes in the way it regulates the products.

Industry report shows bleak 2013 for med tech industry

Things were not looking up for the med tech industry in 2013. A report released today by EP Vantage, "MedTech 2013 In Review," showed worsening market conditions for devicemakers last year, with mergers and acquisitions taking the biggest hit.

Canada issues new ranking system for plant violators

New guidance just published by Health Canada shows it will institute a three-level ranking system for plants divided by high-risk and low-risk products, rather than issue a simple "compliant" or "non-compliant" designation.

Accenture boosts clinical data offerings with Octagon buy

IT consulting giant Accenture has purchased Octagon Research Solutions, looking to offer pharma companies help with streamlining their regulatory filings.

Vertex finds key support for cystic fibrosis drug in Europe

Vertex ($VRTX) has taken another step toward building a global franchise for treating cystic fibrosis. European regulatory advisers backed approval of the trailblazing drug Kalydeco for a subset of patients with the genetic disorder, paving the way for a likely go-ahead to market the drug in the EU.

Forecast: Pharma wants CMO consulting, regulatory support

For 2012, contract manufacturers should brace for an increase in requests for bioanalytical testing, consulting, high-potency compound and regulatory support services. But they should be able to

Cross-pond regulators pilot joint ops

Drug regulators in the U.S and Europe are becoming fast friends. Officials are talking more, according to regulator-panelists at a town hall gathering held this week at the ISPE annual meeting in San