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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.

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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Regulatory Affairs
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WHO: Post-Antimicrobial Era Is a ‘Very Real Possibility’

April 30, 2014

The organization found evidence of resistance rates to some common infections exceeding 50 percent in all continents except Antarctica. Read More

FDA Approves Novartis’ Zykadia for ALK-Positive NSCLC

April 30, 2014

The FDA has approved Novartis’ lung cancer drug Zykadia four months ahead of its Aug. 24 PDUFA date, the Swiss drug giant said Tuesday. Read More

FDA Approves Oral Suspension Drug for Leukemia Combo Regimen

April 29, 2014

The FDA on Monday approved UK-based NOVA Laboratories’ oral suspension drug for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Read More

EMA’s EudraVigilance Report Shows Uptick in Patient-Reported Adverse Events

April 29, 2014

The European Medicines Agency (EMA) says the EU’s EudraVigilance database received more than 1 million post-marketing expedited adverse-drug-reaction (ADR) reports in 2013. Read More

Indian State’s Drug Controller Lifts Wockhardt Suspension

April 29, 2014

The suspension was imposed just last week, though Wockhardt declined to comment on the reasons behind it. Read More

CHMP Recommends Approval of GSK’s Melanoma Treatment

April 28, 2014

A European Medicines Agency committee on Friday recommended approval of GlaxoSmithKline’s melanoma drug Mekinist, the first of its kind treatment that selectively targets the MEK protein kinase. Read More

EMA Considering New Trial Design in Breast Cancer Research

April 28, 2014

The European Medicines Agency (EMA) is considering new trial designs using pathologic complete response (pCR) as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early stage breast cancer. Read More

Canada Offers Guidance on Developing Postmarket Benefit-Risk Assessment

April 25, 2014

Drugmakers providing postmarket benefit-risk assessments to Health Canada will soon need to follow rigid, standardized guidelines that provide both preapproval and postapproval data about a drug product’s efficacy. Read More

EMA Recommends Stripping Domperidone-Containing Drugs of Some Indications

April 25, 2014

The European Commission is moving toward putting new restrictions on drugs that contain domperidone, removing the EC’s approval of the drugs for treatment of bloating and heartburn due to increased heart risks. Read More

Takeda Gets Japanese Pandemic Flu Vaccine Subsidy

April 25, 2014

This is Takeda’s third pandemic vaccine-related subsidy from the Japanese government since 2009. Read More

Hospira Recalls Anesthetic Due to Steel Particles

April 25, 2014

Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More

European GMP Guidelines Pose New Quality Requirements for Drugmakers

April 25, 2014

The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More

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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Biological Risk Evaluation and Management for Medical Devices

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Regulatory Affairs
RSS

WHO: Post-Antimicrobial Era Is a ‘Very Real Possibility’

FDA Approves Novartis’ Zykadia for ALK-Positive NSCLC

FDA Approves Oral Suspension Drug for Leukemia Combo Regimen

EMA’s EudraVigilance Report Shows Uptick in Patient-Reported Adverse Events

Indian State’s Drug Controller Lifts Wockhardt Suspension

CHMP Recommends Approval of GSK’s Melanoma Treatment

EMA Considering New Trial Design in Breast Cancer Research

Canada Offers Guidance on Developing Postmarket Benefit-Risk Assessment

EMA Recommends Stripping Domperidone-Containing Drugs of Some Indications

Takeda Gets Japanese Pandemic Flu Vaccine Subsidy

Hospira Recalls Anesthetic Due to Steel Particles

European GMP Guidelines Pose New Quality Requirements for Drugmakers

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