Topic:

Regulatory

Latest Headlines

Latest Headlines

India's CDSCO moves to expand access to Tamiflu as H1N1 flu spreads

India's CDSCO has requested local regulators to update a 2009 list of the names of pharmacies that are licensed to sell, stock or distribute oseltamavir phosphate (Tamiflu) in India in an effort to facilitate access to medications to combat swine flu (H1N1).

India Finance Ministry kicks the can on Aurobindo, Glenmark foreign investment

India's Finance Ministry kicked the can down the road for another agency to determine whether $67 million worth of foreign direct investment should be opened for Aurobindo Pharma and Glenmark Pharmaceuticals.

FDA warns of device design amid UCLA superbug outbreak

Amid a drug-resistant "superbug" outbreak at the UCLA Health System in California, the FDA is warning doctors and hospitals that endoscope devices' complex design may hinder proper cleaning, contributing to the spread of deadly bacteria.

FDA grants Celgene's Revlimid new use as it moves toward $10B in sales

Celgene's powerhouse cancer drug Revlimid generated nearly $5 billion for the company last year and has now gotten yet another FDA nod which analysts believe will help it double that amount within 5 years.

FDA panel to consider PMA application of spinal implant

The FDA's orthopedic advisory panel will investigate the agency's concerns about fractures to the back of the spine resulting from the investigational VertiFlex Superion Interspinous Spacer as it deliberates on Feb. 20 whether to recommend the device's PMA application for FDA approval.

NICE, drugmakers reject analysis that price watchdog is too generous

Drugmakers are often at odds with the National Institute for Health and Care Excellence (NICE) in England, saying it is stingy in what it will approve as payments for their best new treatments. But the industry and the gatekeeper have pulled together in defending against a study that says NICE is paying drugmakers too much for their best new treatments.

Roche and Exelixis roll toward FDA approval with a melanoma cocktail

Roche and Exelixis are one step closer to FDA approval for their skin cancer-treating combination treatment, as the agency has accepted their application and promised a speedy review.

China FDA draft GCP guidelines in line with harmonization aims

China FDA has issued draft guidelines on changes to good clinical practice guidelines that cover 34 provisions, including the use of outsourced partners in China that are generally in line with international aims of harmonization.

Pakistan's new drug pricing policy to cut some costs by one-third

Pakistan's minister in charge of drug pricing confirmed at a news conference a new policy would reduce the costs of some drugs by as much as 30%, but said no changes would become effective before June 30, 2016.

Indian regulator places 5-year ban on Kivi Labs for forgery

India authorities placed a 5-year ban on Kivi Labs for submitting any filings with the Central Drugs Standards Control Organization after determining the company filed fictitious and forged documents for fixed-dosage combinations.