Merck’s bulk drug substances used to manufacture many of its vaccines are adulterated, and the FDA is requesting a meeting with senior management to expedite the firm’s corrective actions, according to a recent warning letter.Read More
The FDA, industry and Congress all support draft legislation to increase funding for more inspections of foreign manufacturing facilities, but agency officials and lawmakers differ on whether such inspections should be required every two years or prompted by risk-based analyses.Read More
A new guidance aims to help manufacturers prepare abbreviated 510(k)s for hemodialysis blood tubing sets and mitigate risks — such as malfunctions, infections and blood loss — associated with the devices.Read More
Philips Medical Systems received a warning letter for GMP violations related to its computed tomography and nuclear imaging systems, the second GMP-related warning in two months.Read More
To meet a deadline set by the FDA Amendments Act (FDAAA), the FDA and HHS need input from drugmakers, distributors, foreign regulators and other interested parties on how to establish a standard numerical identifier to track drugs in the supply chain.Read More
Following Stryker’s recall and temporary production stoppage of artificial hip components, growth in the company’s hip franchise is expected to slow in the first quarter.Read More
The European Commission (EC) is proposing to expand its regulations on good manufacturing practice (GMP) inspections by allowing member states to conduct both announced and unannounced audits of active pharmaceutical ingredient production facilities.Read More
The U.S. Pharmacopeial (USP) Convention has updated its monograph for glycerin to require manufacturers using its standards to prove that pharmaceutical preparations are free of diethylene glycol.Read More
The FDA’s memorandum of agreement (MOA) with Chinese regulators was put to the test during its investigation into adulterated batches of Chinese-made active pharmaceutical ingredient (API).Read More
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important. But creating an FDA-proof CAPA isn’t easy. If only you could pick the brain of someone who is coping successfully with CAPA — the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA. Well, you can. Register today.Read More
Come for this valuable opportunity to hear FDA officials discuss regulatory plans and objectives — and ask questions you need answered; learn from device industry experts, consultants and other experts with actionable tips and strategies you can take straight back to the office; and network with other professionals who understand your challenges; share war stories and insights over a drink. Register Today.Read More
The FDA’s cadre of freshly trained inspectors — many of whom come directly from industry — and increased focus on specialized inspections are making it harder than ever to predict the outcome of your next FDA inspection. Unless, of course, you have Surviving an FDA Inspection at your fingertips. If you could spend less than $400 to get your drug manufacturing facility fully prepared to face a tough inspection by the FDA, would you even hesitate? ... Of course not!
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