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1,251 Results
Type: News
Section: Industry News > Regulatory
Adherence/Delivery
New dosing feature for Pedia Care and Little Remedies acetaminophen brands
For single-concentration brands of children's products, new packaging helps to protect infants and children under age two.
September 23, 2011
Regulatory
Bill introduced to address pharmaceutical waste
Pharmaceutical Stewardship Act aims to create a national extended producer responsibility program to include pharmaceutical makers in taking back unused meds.
September 22, 2011
Regulatory
Packaging error leads to oral contraceptives recall
Qualitest Pharmaceuticals issues nationwide retail recall of multiple lots of the products due to packaging defects that could leave women without adequate contraception.
September 20, 2011
Regulatory
FDA approach to animal drugs is a balancing act
Agency is reluctant to remove safe, useful animal drugs that lack legal clearance, and seeks public input.
August 30, 2011
Regulatory
Packaging 'pain points' reveal frustrations
Validation, regulatory/standards, and cost issues top the list of laments for respondents of recent Healthcare Packaging reader survey.
August 18, 2011
Regulatory
FDA MedWatch - July 2011 Safety Labeling Changes: 32 products with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions
The MedWatch July 2011 Safety Labeling Changes posting includes 32 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
August 15, 2011
Regulatory
Packaging eases administration, discomfort for four-legged patients
In this Q&A, Farren Paton, packaging engineer for Novartis Animal Health U.S. Inc., discusses the company's latest user-friendly pet packages and other trends in veterinary packaging.
August 11, 2011
Regulatory
World healthcare IT market expected to reach $162.2 Billion by 2015
Report forecasts global healthcare IT market will rise at a Compound Annual Growth Rate of 10.2% from 2010's $99.6 Billion.
August 11, 2011
Nutraceuticals/Dietary
'Lazy Larry' responds to FDA notification
A July 28 Warning Letter from the U.S. Food and Drug Administration serves as a reminder of the power of the pen--or in this instance, the words printed on product packaging.
August 9, 2011
Regulatory
Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events
[UPDATED 07/22/2011] FDA has approved an updated drug label for Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking--those with cardiovascular disease and those with chronic obstructive pulmonary disease (COPD).
August 8, 2011
Regulatory
June 2011 Safety Labeling Changes: 50 products with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions
The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm261325.htm Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
August 8, 2011
Regulatory
Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)
Tamiflu will undergo labeling changes to reduce possibility of prescribing and dosing confusion.
August 8, 2011
Regulatory
Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor
McNeil Consumer Healthcare recalls one product lot of Tylenol Extra Strength Caplets, 225 count bottles.
August 8, 2011
Medical Device/Packaging
Contesting the 510(k)
The 510(k) program to bring medical devices to market incites passionate responses from industry groups.
August 5, 2011
Regulatory
Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency
American Regent announces voluntary recall of multiple lots of Vasopressin Injection, USP to the Retail/Hospital level.
August 4, 2011
Materials
FDA approves vaccines for the 2011-2012 influenza season
Six manufacturers are licensed to produce and distribute vaccines to battle the flu, which leads to more than 200,000 hospitalizations a year, and between 3,000 and 49,000 deaths annually in the U.S.
July 19, 2011
Regulatory
Supreme Court issues pre-emption decision involving generics
Late June ruling says persons injured by generic drug products can no longer claim that the generic company failed to warn them about specific hazards.
July 13, 2011
Pharmaceuticals
The job market: Not so healthy--or is it?
A 9.2% unemployment rate is disturbing, but there appears to be cause for optimism regarding healthcare packaging-related jobs.
July 12, 2011
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