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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.

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Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

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Regulatory Affairs
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President’s HHS Budget Incorporates Drug Pricing Reforms

February 12, 2016

Buried deep in the administration’s budget proposal are a series of drug price control measures that could rattle the pharmaceutical industry. Read More

Senate Schedules Vote on Califf for FDA Top Job

February 12, 2016

The full Senate is scheduled to decide on Feb. 22 whether Robert Califf should be the next FDA commissioner, after Majority Leader Sen. Mitch McConnell (R-Ky.) scheduled a cloture vote late Thursday. Read More

FDA Proposes Sponsors Collect Fewer Data on Non-serious Adverse Events

February 11, 2016

Drug sponsors may be able to collect fewer data for non-serious adverse events for late-stage clinical trials and postapproval studies. Read More

Paper: U.S., EU Generics Standards Should Be Synced

February 11, 2016

European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Read More

Mylan Announces Meda Purchase for $7.2B

February 11, 2016

Generics giant Mylan N.V. has struck a tentative deal to purchase Swedish drugmaker Meda AB for $7.2 billion in cash and stock. Read More

Wockhardt CEO: Company to Resolve ‘Minor’ Form 483 Issues With FDA

February 11, 2016

Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More

Report: NHS England, Health Dept. Failing to Manage CDF Effectively

February 11, 2016

The UK’s Department of Health and NHS England have failed to manage the Cancer Drugs Fund effectively by not carrying out its intended purpose and significantly outspending its budget, according to a report released by the UK Parliament’s House of Commons. Read More

New Zealand Signs Off on TPP While Protestors Hit PhRMA Headquarters

February 11, 2016

New Zealand signing off on the Trans-Pacific Partnership on Feb. 3 should start the clock ticking for ratification of the treaty, which provides up to eight years of exclusivity for biologics. Read More

Roche Cooperates With India Probes Into Off-Label Avastin Use

February 11, 2016

Roche says it is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin were halted after 15 patients experienced pain and swelling in their eyes. Read More

UK Health Cost Watchdog Smiles on Drugs for Cancer, Arthritis, Lung Disease

February 11, 2016

The UK’s National Institute for Health and Care Excellence has issued recommendations for NHS to reimburse the use of seven biologicals in treating severe rheumatoid arthritis, along with four new cancer treatments and a lung disease therapy. Read More

OMQ’s End-of-Year Review Finds Many Issues With Overseas cGMP Practices

February 11, 2016

The FDA repeatedly blasted overseas drugmakers last year for disregarding compliance orders and not living up to their own promises to carry out proper cGMP practices for active pharmaceutical ingredients. Read More

NHS England, Department of Health Failed to Manage CDF, Report Finds

February 11, 2016

The agencies have not been carrying out the fund’s intended purpose and significantly outspending its budget. Read More

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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

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Regulatory Affairs
RSS

President’s HHS Budget Incorporates Drug Pricing Reforms

Senate Schedules Vote on Califf for FDA Top Job

FDA Proposes Sponsors Collect Fewer Data on Non-serious Adverse Events

Paper: U.S., EU Generics Standards Should Be Synced

Mylan Announces Meda Purchase for $7.2B

Wockhardt CEO: Company to Resolve ‘Minor’ Form 483 Issues With FDA

Report: NHS England, Health Dept. Failing to Manage CDF Effectively

New Zealand Signs Off on TPP While Protestors Hit PhRMA Headquarters

Roche Cooperates With India Probes Into Off-Label Avastin Use

UK Health Cost Watchdog Smiles on Drugs for Cancer, Arthritis, Lung Disease

OMQ’s End-of-Year Review Finds Many Issues With Overseas cGMP Practices

NHS England, Department of Health Failed to Manage CDF, Report Finds

Recommended Products

Events

Editor's Picks

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Regulatory Affairs
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