We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?
The author discusses the regulatory requirements for electronic records contained in Title 21 CFR Part 211 and how they overlap with the requirements set forth in Title 21 CFR Part 11.
GlaxoSmithKline has announced that it will acquire Human Genome Sciences (HGS) for $14.25 per share in cash, or approximately $3.6 billion on an equity basis.
Par Pharmaceuticals, a maker of generic drugs, has entered into an agreement to be acquired by the private investment firm, TPG, for $1.9 billion.
FDA promotes supply chain pilot program. EMA opens pharmacovigilance legistation up for public consultation. USP Calls for Somatropin Cell-Based Bioidentity Method.
Global spending on medicines is estimated to reach nearly $1.2 trillion by 2016.
Amgen Completes Acquisition of KAI Pharmaceuticals; Renaissance Acquisition Holdings Acquires DPT Laboratories; and More.
Highlights of UN Conference on Sustainable Development, held in Rio de Janeiro, Brazil, last month and related industry initiatives.
On July 9, 2012, FDA approved a risk evaluation and mitigation strategy for extended-release and long-acting opioid medications.
On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.
ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.
GSK Extends Deadline for Tender Offer to Acquire Human Genome Services; Sartorius Opens New Filter, Aseptic-Bag Production Facility in Puerto Rico; and More.
FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.
GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability resulting from unlawful promotion of certain drugs, failure to report safety data, and alleged false price reporting practices.
Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.
EMA and MHRA provide insight into increased GMP deficiencies.
Careful attention to detail will help to prevent valuable assets from "melting" away.
Taking time to appreciate the industry's greatest achievements will inspire growth ahead.
Bristol-Myers Squibb has agreed to acquire the biopharmaceutical company Amylin Pharmaceuticals for a purchase price of $5.3 billion and an additional $1.7 billion for assuming Amylin's net debt and a contractual payment obligation to Eli Lilly based on Amylin's recently terminated agreement with Eli Lilly over the diabetes drug exenatide.
Presidents of leading associations offer views on the industry's future.
Parallel trade has frustrated pharmaceutical manufacturers for years and now evidence has linked such trade to drug shortages in Europe. Parallel trade representatives have yet to respond, but will need to react quickly to salvage their reputation.
In a 5–4 vote, the Supreme Court has ruled in favor of the Constitutionality of the Affordable Care Act.
In a 5-4 ruling, the US Supreme Court upheld the provision of the Affordable Care Act requiring all adults to purchase health insurance or pay a penalty—the so-called individual mandate.
Bend Research, Catalent Enter into Oral Controlled-Release Technologies Pact; Quintiles Expands in China; and More.
The European Medicines Agency has published its first set of finalized guidelines concerning good pharmacovigilance practices.
The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.
Roche announced that it will be closing its R&D site in Nutley, New Jersey, eliminating approximately 1000 positions.
FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research.
US court ruled in favor of Teva in its patent-infringement lawsuit against Momenta and Mylan's generic versions of Teva's Copaxone.
US District Court for NJ Rules Against Merck & Co. in Nasonex Patent Infringement Case; FDA Issues Complete Response Letter to Pfizer for Tafamidis Meglumine NDA; and More.