So, you have just been granted a face-to-face (FTF) meeting with the FDA. Woohoo! You’re going to Bethesda! Don’t be too quick to make those plane and hotel reservations. This morning, the FDA published a clarification from the FDA, CDER, Small Business and Industry Assistance (SBIA) program in its INDUSTRY NEWS section titled FDA Describes […]
As Lester Holt says at the introduction of the last show segment on NBC Nightly News – “There’s good news tonight”. The same might be said of the recently released GDUFA II Quarterly Performance Report (here). The figures for the fourth quarter have some really good news. First, the number of ANDA awaiting FDA action […]
I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida. The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations. The conference was well attended by both industry and regulators. Although I found all of the […]
At the first highly attended ISPE Annual meeting since the pandemic hit, the themes that kept emerging from both sessions and attendees was convergence and collaboration. This concept reached its peak at the sessions that ended this conference, with a keynote from Peter Marks, MD/PhD, Director, CBER, FDA, the Regulatory Town Hall featuring representation from […]
Today the FDA issued a guidance entitled Cross Labeling Oncology Drugs in Combination Regimens (https://www.fda.gov/media/162806/download) that describes the Agency thinking on cross labeling of oncology drugs for which there is a proven benefit from their combined use. As I read the guidance a few things popped into my mind. How can one firm who owns […]
Wednesday, November 16th, 10:00 AM ET Presented by Informa Pharma Intelligence and Lachman Consultants HOSTED BY Maire Gerrard Managing Editor, Custom Content, Pharma Intelligence The life sciences industry is currently experiencing a period of sweeping digital transformation, propelled by initiatives like Pharma 4.0™ and progress in embedding artificial intelligence (AI), machine learning (ML), and robotic […]
Dispensary of Hope, a Nashville-based organization with a national model of medication access for the most vulnerable, has appointed Robert “Bob” Pollock, M.S., Senior Advisor, Outside Director to the Board at Lachman Consultants, Inc. to its National Advisory Council. The organization’s many years of growth and commitment to serve are empowered by individual servants and […]
For those of you in the OTC monograph world (not OTC products that require an approved NDA or ANDA application for marketing), this draft guidance document, titled Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (here), will provide you with the how, what, and when information about facility fees for dosage-form manufacturers […]
Data integrity is not only fundamental to a company’s license to operate and to drive new stakeholder value. It’s simply smart business. Does your company have a sustainable, cost-effective global data governance program? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely […]
On Tuesday, November 8, 2022, as part of the GRx+Biosims conference being held by the Association for Accessible Medicines, Marty Shimer will be participating on a panel in the Science and Regulatory Learning Track on pH Adjusters and Q1/Q2 Assessments. This session will explore FDA’s plans for pH adjusters and Q1/Q2 assessments and provide industry […]
