Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Electronic security access to the pharmacy and video monitoring. -

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Alta Sciences

MAY 15, 2023

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion , without, for the most part, shorter development timelines. Altasciences has U.S.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 11, 2023

In addition, it may also be unethical to operate a control arm in some cases, such as when there is no currently marketed treatment option for a life-threatening disease. In other cases, patients may not wish to enroll in a study if there is a chance they would not benefit, as would be the case if they might receive a placebo.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

JUNE 16, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. the drug and device) of the combination product.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40