Advertisement
Government and Regulatory
Subscribe to Government and Regulatory

The Lead

Facing Health Law Hikes, Consumers Mull Options

November 25, 2014 1:34 pm | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

Consumers across most of America will see their health insurance premiums go up next year for popular plans under President Barack Obama's health care law.                

FDA Approves Valeant’s ONEXTON Acne Gel

November 25, 2014 8:13 am | News | Comments

Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin...

Aurobindo Pharma Recalls Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules

November 24, 2014 3:04 pm | News | Comments

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg...

FDA Issues Additional Guidance for Outsourcing Facilities That Compound Sterile Human Drugs

November 24, 2014 1:18 pm | News | Comments

The FDA has issued three additional policy documents to assist entities that compound sterile...

View Sample

FREE Email Newsletter

FDA Approves Hard-to-Abuse Hydrocodone Pill

November 20, 2014 3:27 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health regulators have approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking such safeguards.       

Report: Sub-Standard Medicine Floods Afghan Market

November 19, 2014 8:08 am | News | Comments

Half of all medicine available on the Afghan market has either been smuggled into the country or made under sub-standard conditions in neighboring Pakistan, according to a report released on Wednesday.        

Administration Says HealthCare.gov Working Well

November 18, 2014 9:07 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

As a crucial second sign-up season gears up, the Obama administration said Sunday that HealthCare.gov is stable and working well, a far cry from last year's frozen computer screens and frustrated customers.          

Advertisement

Lemtrada Approved for Multiple Sclerosis

November 17, 2014 8:18 am | News | Comments

The U.S. Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. The drug has already been approved by the European Medicines Agency for use in the European Union and in Canada and Australia.

FDA Approves Janssen’s Schizoaffective Disorder Treatment

November 13, 2014 1:53 pm | News | Comments

Janssen Pharmaceuticals has announced that the FDA approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.

Missouri Panel Formed to Investigate Attorney General Koster’s Pharmaceutical Ties

November 12, 2014 3:03 pm | by SUMMER BALLENTINE, Associated Press | News | Comments

Missouri House Speaker Tim Jones on Wednesday created a committee of lawmakers to review allegations that Attorney General Chris Koster has been influenced by lobbyist perks and campaign contributions.         

FDA Approves Par Pharmaceutical’s Vasostrict Injection

November 12, 2014 8:08 am | News | Comments

Par Pharmaceutical Companieshas received approval for its New Drug Application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the U.S. Food and Drug Administration (FDA) pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

VA Chief Announces Sweeping Reforms

November 11, 2014 8:49 am | Videos | Comments

Veterans Affairs Secretary Robert McDonald announced the largest restructuring in the agency's history in the wake of a scandal over delayed care.                  

Advertisement

Administration Dials Back Goal for Health Law Sign-Ups

November 10, 2014 3:36 pm | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

With sign-up season launching this weekend, the Obama administration sharply dialed down expectations Monday for the second year of the president's push to provide health insurance for all Americans.         

Supreme Court Will Look at 'Obamacare' Subsidies

November 10, 2014 8:43 am | by MARK SHERMAN, Associated Press | News | Comments

The Supreme Court has agreed to hear a new challenge to President Barack Obama's health care law — a case that threatens subsidies that help millions of low- and middle-income people afford their health insurance premiums.     

Mexican Meth Increasingly Supplanting At-Home Labs

November 10, 2014 8:21 am | by JIM SALTER, Associated Press | News | Comments

The nation's Heartland is ridding itself of the scourge of homemade methamphetamine, with lab seizures down by nearly half in many high-meth states. Any celebration is muted: Meth use remains high, but people are increasingly turning to cheaper, imported Mexican meth rather than making their own.

FDA Approves Ipsen's New Delivery Device for Somatuline® Depot® (lanreotide) Injection

November 6, 2014 11:44 am | News | Comments

Ipsen Biopharmaceuticals announced that the FDA has approved a new device to deliver Somatuline® Depot® (lanreotide). The device has an enhanced, prefilled, low-volume syringe that supports full-dose delivery with no reconstitution requirements.

FDA Approves Ranbaxy’s Fenofibrate Capsules

November 6, 2014 8:43 am | News | Comments

Ranbaxy Labs has received approval from the FDA to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively.

Advertisement

Serialization: Don’t Wait Until the Last Minute

October 30, 2014 11:11 am | by Kevin Swartz, Senior Engineer, IPS; Tina Gushue, Process Engineer, IPS | Blogs | Comments

A reminder to pharma manufacturers, the Drug Supply Chain Security Act (DSCSA) deadlines are quickly approaching. Have you planned for the implementation of Transaction Documents for your packaged products and how to introduce them into your supply chain? Have you developed a strategy for implementing packaging serialized data and infrastructure?

FDA Approves Once-Daily XIGDUO™ XR Tablets for Adults with Type 2 Diabetes

October 30, 2014 8:04 am | News | Comments

AstraZeneca today announced that the FDA has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.               

FDA Grants Accelerated Approval to Pfizer’s TRUMENBA®

October 29, 2014 3:22 pm | News | Comments

Pfizer announced that the FDA has granted accelerated approval of TRUMENBA ® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

North Dakota Court Bans Use of Drug in Abortions

October 29, 2014 8:44 am | by JAMES MacPHERSON, Associated Press | News | Comments

The North Dakota Supreme Court on Tuesday upheld a state law that limits the use of drugs to perform abortions, a move abortion-rights supporters say will end the use of medications to perform the procedure.       

States Ask Congress to Intervene on Drug Prices

October 29, 2014 8:24 am | News | Comments

In a letter Tuesday to key congressional committees, the National Association of Medicaid Directors said lawmakers should consider everything from outright price controls on manufacturers to federal help for states trying to pay for the new medications.

New Warning for Dietary Supplement Users

October 23, 2014 10:46 am | Videos | Comments

Researchers at Harvard found that two-thirds of dietary supplements that have previously been recalled still contain banned ingredients. Also, smoking may get in the way of recovering alcoholics.         

HealthCare.gov's EZ Form Not for Legal Immigrants

October 23, 2014 8:26 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

HealthCare.gov's new EZ application for coverage can't be used by legal immigrants or naturalized U.S. citizens, prompting concern that many Hispanics and Asians will go right back into long enrollment queues this year.      

Study Finds Drugs Still in Recalled Supplements

October 22, 2014 8:58 am | by LINDSEY TANNER, AP Medical Writer | News | Comments

Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. In supplements bought online, researchers detected hidden steroids, similar ingredients to Viagra and Prozac and a weight loss drug linked with heart attacks.

Packaging Error Prompts Recall of Naproxen Pills

October 21, 2014 11:48 am | News | Comments

A North Carolina company is recalling nearly 12,000 boxes of pain relief tablets sold at Dollar Tree stores because some cartons contain a different medication that could cause allergic reactions.         

Halozyme Receives FDA Approval for Additional Manufacturing Facilities For Hylenex Recombinant

October 20, 2014 9:02 am | News | Comments

The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.

FDA Panel Votes to Keep Boxed Warning on Chantix

October 16, 2014 4:36 pm | by The Associated Press | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.

FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

October 16, 2014 8:41 am | News | Comments

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.  

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading