An Update on the Nomination of FDA Commissioner Robert Califf - Policy and Medicine

Read the full report: An Update on the Nomination of FDA Commissioner Robert Califf - Policy and Medicine:

"An increasing number of senators are threatening to block Dr. Robert Califf's nomination to be the next Commissioner of the U.S. Food and Drug Administration. The story illustrates an unusual coalition of right and left-leaning members of the Senate, and common refrains about "industry ties" in government and medicine. Ultimately, arcane Senate rules allow the entire process to be stalled by these individual members of the body."

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FDA Orange Book - Newest Annual Edition Has Arrived!

It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs | FDA Voice

Read the full blog post: Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs | FDA Voice:

"To clarify the mission and scope of the ETT, we’ve recently issued a draft guidance titled, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. It provides recommendations to pharmaceutical companies on effective ways to work with the ETT. The document explains the ETT and provides specific recommendations to drug manufacturers for obtaining important early feedback from the FDA regarding their efforts to develop novel manufacturing technologies."

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FDA To Inspect Facilities Using Novel Sterilization Methods

The FDA has released this guidance document:

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff

"We believe that novel sterilization technologies carry a substantial risk of inadequate sterility assurance if not conducted properly. Consequently, compliance with GMP for devices sterilized using these technologies should be closely evaluated. Failure to assure sterility presents a serious risk to human health because of the risk of infection. Therefore, we intend to inspect the manufacturing facility before clearing a 510(k) for a device that is sterilized by a novel sterilization process. Inspecting the manufacturing facility for devices sterilized using these sterilization technologies will help ensure the safety and effectiveness of these devices and mitigate the risks to human health."

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FDA outlines cybersecurity recommendations for medical device manufacturers

Read the full article:  Press Announcements > FDA outlines cybersecurity recommendations for medical device manufacturers - FDA.gov:

"The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market. The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats."

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Read the FDA draft guidance:
Postmarket Management of Cybersecurity in Medical Devices (PDF)

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FDA - Proposed 2016 Guidance Development & Focused Retrospective Review of Final Guidance

According to the FDA:

" . . .guidance documents that CDRH intends to publish this fiscal year (FY2016), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn. We have provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents that issued in 2006, 1996, 1986, and 1976 subject to focused retrospective review."

Go to this FDA webpage:
CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance


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F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval - The New York Times

Read the full article: F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval - The New York Times:

"In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and a passion to fight the disease that patient advocates thought he lacked."

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Robert Califf, F.D.A. Nominee, Queried on Industry Ties - The New York Times

• Trusted FDA CGMP online training courses sold by SkillsPlus International Inc.

Read the full report:  Robert Califf, F.D.A. Nominee, Queried on Industry Ties - The New York Times:

"President Obama’s nominee to lead the Food and Drug Administration, Dr. Robert M. Califf, coasted through a confirmation hearing on Tuesday, with most members of a Senate committee — including some who have been skeptical about his ties to the pharmaceutical industry — seeming set to support his candidacy."

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Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases | OPA | Department of Justice

Read the full press release: Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases | OPA | Department of Justice:

"Criminal Charges Brought against Bestselling Supplement Manufacturer

As part of a nationwide sweep, the Department of Justice and its federal partners have pursued civil and criminal cases against more than 100 makers and marketers of dietary supplements.  The actions discussed today resulted from a year-long effort, beginning in November 2014, to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide.  In each case, the department or one of its federal partners allege the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.

Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers.  USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro."

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Free GMP Training Tips - A Focus On Class Times & More

For optimal throughput, choose class schedules & format wisely.

Coordinate training schedules for maximum gain

Give some thought on how to minimize the impact on production and other critical daily work responsibilities. Unless your production lines are down, you'll want to make sure production quality doesn't suffer. For some, even though they're in class, their minds are elsewhere (distracted by what's waiting for them back at their desks). Try to limit putting extra demands & stress on staff (for example, a stressor such as asking staff to attend class before/after their normal work shift, especially if they work 3rd shift). Here are a few ideas:

• Split it.  If the course is 8 hours long, split the classroom time in half, and conduct the class over a 2 day period.
• Deliver training at some time other than regular shift hours (this might be obvious). And be sure to consider offering training on the weekend.

Choose the best format & venue

• Chunk training into digestible sessions. It's important to create an effective learning experience. For content heavy topics or workshop courses, it might make sense to split it up to avoid full day training overload, and give a little time for homework or just a breather to let it all sink in. 
• Sometimes you have no choice but to get very larger numbers of employees through training as fast as possible. One possibility is to use a large venue (for example, an auditorium or conference facility) to meet your training goals & objectives, and achieve the necessary training throughput.

Get a trainer that teaches at your desired times

The right training vendor will do their best to accommodate your unique site and staffing situation to deliver training courses at the times that work best for you. For example, explore having the trainer teach a class during 3rd shift or on the weekend.

Do these tips touch on your situation, and you need GMP training?

If you said yes:

• Learn more about cGMP training courses taught by SkillsPlus International Inc.

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