Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in…
A June FDA inspection left a Washington state pharmacy and compounder with a Form 483 citing unsafe production practices that could lead to drug contamination. Source: Drug Industry Daily
In the second day of a two-day meeting, an FDA pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while…
The FDA plans to use its emerging technology program to help address key pharmaceutical quality and manufacturing challenges — and also train agency reviewers on the latest processes to keep…
Senate Republicans unveiled their hotly anticipated version of a bill to replace the Affordable Care Act Thursday, which includes the repeal of a pharmaceutical industry tax. Source: Drug Industry Daily
The FDA cautioned manufacturers and consumers that a collection of supplements are illegally marketed drugs containing so-called designer steroids, issuing three warning letters to Flex Fitness/Big Dan’s Fitness, AndroPharm and…
The FDA is changing its labeling requirements for injectable drug products that contain a single active ingredient — swapping ratios of strength with amounts per unit of volume — in…
An FDA pediatric cancer advisory panel called on multiple sponsors to continue refining their cancer drugs to adapt them for safe and effective use in pediatric populations. Source: Drug Industry…
The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be…
FDA Commissioner Scott Gottlieb outlined an action plan to remove barriers to generic competition, saying agency regulations have been “gamed” by brand-name manufacturers to delay generic drug approvals even after…