Content about Regulatory and Washington

February 13, 2013
Persistent shortage of primary care, specialist physicians found in New York state

A new report indicates that a shortage of physicians could adversely affect the implementation of healthcare reform.

February 13, 2013
Small increase in January retail sales indicate 'stable yet fragile economy,' NRF says

Retail sales were up slightly in January as the increases in payroll taxes and energy prices forced consumers to change spending habits, according to a new report by the National Retail Federation.

February 13, 2013
State of the Union address draws mixed responses from drug industry

Some people liked President Barack Obama's State of the Union address Tuesday night, and some people didn't, and the response from the drug industry was no less mixed.

February 12, 2013
Post-approval drug problems could be due to poor adherence in trials, study finds

Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

February 12, 2013
Tough new regulations for compounding pharmacies could be on the way, attorney says

Massachusetts and New Jersey lately have been cracking down on sterile compounding pharmacies alleged to violate safety regulations, but the crackdown may soon go nationwide, predicted a legal firm focused on the matter.

February 11, 2013
AHRQ contest winners announced

The Agency for Healthcare Research and Quality has announced the winners of a competition it sponsored to increase awareness and use of evidence-based healthcare tools in retail health settings, the government agency said.

February 11, 2013
FDA turns down two Novo Nordisk insulin products

The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.

February 11, 2013
Shire to pay Impax $48 million in authorized generic Adderall XR case

Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

February 11, 2013
Titan Medical Enterprises shut down after violating drug, supplement good manufacturing practices

A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported.

February 8, 2013
FDA approves generic diabetes drug

The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

February 8, 2013
FDA approves multiple myeloma drug

The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

February 8, 2013
FDA approves Warner Chilcott ulcerative colitis drug

The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.

February 8, 2013
FDA gives tentative approval to Dr. Reddy's hypertension drug

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

February 8, 2013
Flu still 'Texas big' in the Lone Star and neighboring states

For the week ended Feb. 2, influenza activity remained elevated in the United States but decreased in most areas, the Centers for Disease Control and Prevention reported Friday.

February 8, 2013
Report: New FDA switch paradigm could bring $36 billion in prescription revenue to the front end

A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International.

February 8, 2013
Reports: Amgen plans six biosimilars

Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

February 8, 2013
Reports: Mass. health authorities shut down 10 compounding pharmacies over violations

Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

February 8, 2013
Reports: Obama re-nominates acting CMS administrator to lead agency

President Obama has re-nominated Marilyn Tavenner as administrator of the Centers for Medicare and Medicaid Services, according to published reports.

February 8, 2013
Smoking rates significantly higher among mentally ill, report finds

Smoking among adults with mental illnesses is 70% higher than among those without them, according to a new report from the Centers for Disease Control and Prevention.

February 8, 2013
Va. pharmacy students visit state legislators

An annual event at the Virginia state General Assembly drew several students from a local pharmacy school.

February 7, 2013
CMS study further proof community pharmacy can improve patients' lives, says NACDS

National Association of Chain Drug Stores president and CEO Steve Anderson, calls a new study by the Centers for Medicare and Medicaid Services “further proof of community pharmacy’s ability to improve patients’ lives while making healthcare more affordable in this country.”

February 7, 2013
Survey: Part D 'preferred pharmacy' provision driving rural seniors away from community pharmacy

A survey of community pharmacists suggests that "preferred pharmacy" Medicare Part D drug benefit plans may pose challenges for seniors in rural communities.

February 7, 2013
Vaccine-resistant whooping cough bacteria strain may have appeared in U.S., researchers say

A new strain of the bacterium that causes whooping cough immune to vaccines may have appeared in the United States, according to a brief published in the New England Journal of Medicine.

February 6, 2013
FDA approves Elite Pharmaceuticals' opioid painkiller

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

February 6, 2013
FDA approves Sandoz antibiotic

The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

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