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FDA, USP Enlist Industry’s Help in Improving OTC Drug Quality

FDA and U.S. Pharmacopeial Convention (USP) officials say proactive industry participation — mainly by offering up drug samples and technical information — is vital to improving the quality of OTC finished drugs, the subject of recent high-profile recalls. Read More
 

Report Points to Steep Four-Year Rise in Device Warning Letters

The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds. Read More
 

Anvisa Harmonizes Device, IVD GMPs

Brazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013. Read More
 

‘Significant Decision’ Clarified in CDRH Appeals Guidances

CDRH Friday released two guidances aimed at clarifying the center’s appeals process and bringing it in line with last summer’s FDA Safety & Innovation Act. Read More
 

Biotest Recalls Biologic Drug Due to Particles

Just two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles. Read More
 

Ranbaxy and Justice Settle Manufacturing Compliance Case

Generic drugmaker Ranbaxy announced May 13 it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York. Read More
 
  • TOP STORIES 
  • TOP DEVICE STORIES
  • TOP DRUG STORIES 
  • RSS 

Report Points to Steep Four-Year Rise in Device Warning Letters

The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds. Read More
 

Anvisa Harmonizes Device, IVD GMPs

Brazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013. Read More
 

‘Significant Decision’ Clarified in CDRH Appeals Guidances

CDRH Friday released two guidances aimed at clarifying the center’s appeals process and bringing it in line with last summer’s FDA Safety & Innovation Act. Read More
 

Philippines Revises Registration Policy

The Philippines has completed the transfer of regulatory authority for medical devices from the Food and Drug Administration to the Center for Device Regulations, Radiation Health and Research. Read More
 

TGA Clarifies Implant Reclassification Fees

Manufacturers transitioning hip, knee or shoulder joint replacement implants to Class III will not have to pay the US $1,190 annual application fee until July 1 2014, if the application is approved before June 30, 2013 and the Class IIb listing on the Australian Register of Therapeutic Goods is removed. Read More
 

FDA Wants Basic Testing, Stronger Warnings on Tanning Bed Lamps

Makers of ultraviolet sunlamps used in tanning beds would have 15 months to submit 510(k)s demonstrating safety, if an FDA proposed rule takes effect. Read More
 
  • TOP STORIES 
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Biotest Recalls Biologic Drug Due to Particles

Just two months after its first commercial sale, Biotest Pharmaceuticals has voluntarily recalled one lot of its immunodeficiency drug Bivigam due to visible particles. Read More
 

Ranbaxy and Justice Settle Manufacturing Compliance Case

Generic drugmaker Ranbaxy announced May 13 it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York. Read More
 

FDA to Judge: Enforcement Decisions Are Discretionary

Blocking imports of every shipment of active pharmaceutical ingredient intended for compounding is an impossible feat requiring resources beyond the FDA’s means, the agency told an appeals court last week, calling KV Pharmaceuticals’ claims it should have done so “absurd.”  Read More
 

Ohm Labs Gets 483 for Failure to Address Blue Glass

Ranbaxy subsidiary Ohm Laboratories received a Form 483 for quality control lapses surrounding blue glass in the active pharmaceutical ingredient for atrovastatin calcium tablets. Read More
 

Q&A Guidance Documents Address IND Access, Concerns

The FDA on May 8 issued two draft question-and-answer guidances intended to clear up industry confusion about how it charges patients for INDs during clinical trials and how it expands access to such drugs outside of the clinical arena.  Read More