Blood & Blood Products

by Pill Pals Customer Service | Sep 10, 2025 | News

Image The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes...

FDA approves selumetinib for pediatric patients 1 year of age and olde

by Pill Pals Customer Service | Sep 10, 2025 | News

On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform...

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged

by Pill Pals Customer Service | Sep 10, 2025 | News

Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 03, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Oxycodone HCl tablet Company Name: KVK-Tech, Inc. Brand Name: Product Description:...

Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product

by Pill Pals Customer Service | Sep 10, 2025 | News

Summary Company Announcement Date: January 09, 2023 FDA Publish Date: January 09, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product discoloration Company Name: Spectrum Laboratory Products Inc. Brand Name: Product Description: Company...

FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse

by Pill Pals Customer Service | Sep 10, 2025 | News

For Immediate Release: September 10, 2025 Despite recent declines, opioids remain commonly prescribed to about 1 in 5 U.S. adults who live with chronic pain as effective alternatives are limited. As part of its broader strategy to address the opioid crisis, the U.S....

Development of Non-Opioid Analgesics for Chronic Pain

by Pill Pals Customer Service | Sep 10, 2025 | News

Docket Number: FDA-2025-D-0610 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Non-Opioid Analgesics...

FDA Launches Crackdown on Deceptive Drug Advertising

by Pill Pals Customer Service | Sep 9, 2025 | News

For Immediate Release: September 09, 2025 The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. Today, the FDA is sending thousands...

FDA approves gemcitabine intravesical system

by Pill Pals Customer Service | Sep 9, 2025 | News

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or...

OPDP eCTD

by Pill Pals Customer Service | Sep 9, 2025 | News

On June 24, 2019, FDA issued a final guidance for industry entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format–Promotional Labeling and Advertising Materials for Human Prescription Drugs. This guidance finalizes the draft guidance...