Content about Center for Drug Evaluation and Research

February 18, 2014

In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections.

SILVER SPRING, Md. — In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections. 

December 18, 2013

The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

WASHINGTON — The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

October 31, 2013

The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

SILVER SPRING, Md. – One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

In a memo sent out to staff, Center for Drug Evaluation and Research director Janet Woodcock wrote that she would not retire, but was becoming "more deeply involved" in such activities as proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

September 20, 2013

Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said.

ALLEGAN, Mich. — Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said Friday.

The Allegan, Mich.-based drug maker announced the appointment of Keith Webber as head of regulatory review, a position in which he will start on Oct. 21. Webber previously served as acting director of the FDA's Office of Pharmaceutical Science, part of the Center for Drug Evaluation and Research, which regulates prescription and OTC drugs. He also served as director of the Office of Generic Drugs.

September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

SILVER SPRING, Md. – The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

September 12, 2013

The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

SILVER SPRINGS, Md. — The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

In a memo to staff of the agency's Center for Drug Evaluation and Research, center director Janet Woodcock wrote that for fiscal year 2013, the FDA hired 234 people as part of the Generic Drug User Fee Amendments Human Capital Team. The goal was to hire 231 as part of a three-year push in which it hopes to hire 921, including 461 during fiscal year 2014.

September 10, 2013

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

July 9, 2013

The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said Tuesday.

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

NEW YORK — The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

CDER director Janet Woodcock wrote that the FDA had collected more than $255 million under the Generic Drug User Fee Amendments to the 2012 Prescription Drug User Fee Act reauthorization. The agency plans to collect $299 million in fiscal year 2013.

April 16, 2013

The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.

March 29, 2013

The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

March 19, 2013

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

March 22, 2012

The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing.

SILVER SPRING, Md. — The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing held here.

January 3, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

December 7, 2011

Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

December 7, 2011

Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

November 3, 2011

The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

September 12, 2011

The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

The FDA said it would rename the Office of Oncology Products the Office of Hematology and Oncology Products. The office, which is responsible for reviewing regulatory applications for pharmaceutical and biotech drugs for cancer, is overseen by the Center for Drug Evaluation and Research. Office of Oncology Products director Richard Pazdur will continue as director of the OHOP.

August 4, 2011

The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

SILVER SPRING, Md. — The Food and Drug Administration has reorganized the Office of Generic Drugs in an effort to improve efficiency, according to an internal memo.

The new organizational scheme will add a new division to the bioequivalence program called Division of Bioequivalence II and a new chemistry division, Division of Chemistry IV.

May 10, 2011

The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

NEW YORK — The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

March 14, 2011

McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.

FORT WASHINGTON, Pa. — McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.

The consent decree is subject to approval by the U.S. District Court for the Eastern District of Pennsylvania.