Application Note: How to Respond to (and Avoid) Form 483s

This application note gives a 10 point plan for responding to a Form 483 and features several excerpts from common deviations noted in Form 483s.

Aug 13th, 2013

Four DSCSA Guidances Were Released this Summer: Are You Up to Date?

Read what’s new on DSCSA regarding suspect and illegitimate product, product identifiers, and enhanced drug distribution security at the package level.

Photo credited to Fresenius Kabi.

Fresenius Kabi Goes Above and Beyond DSCSA Requirements

With the support and standards of GS1 US, the pharmaceutical manufacturer fulfills customer needs for an additional system to ensure safe use of medication on a unit-of-use level.

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FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)

The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Guidance for industry and FDA staff. Comments can be submitted.

As Marijuana Business Daily's Omar Sacirbey writes, “The move will allow greater research into marijuana and its potential medicinal properties.'

One Step Closer to Cannabis Access for Medical Research

After years of dragging their heels on approving marijuana cultivation applications for research, the DEA looks to be moving forward with licenses soon.

Healthcare Packaging's Life Science Logistics Playbook

Healthcare Packaging's Life Science Logistics Playbook

Shipping temperature-controlled products? Get tips on preventing excursions and waste, developing a validation master plan, characterizing shipping lanes, and more.

Check out the links to our coverage of the 2021 PDA Annual Meeting. While the live event has passed, the event site is full of on-demand content covering pharmaceutical filling, supply chain considerations, vaccine manufacturing, and more through May 16.

2021 PDA Annual Meeting: Trend Roundup

The Parenteral Drug Association (PDA) virtual conference offered plenty of new perspectives in aseptic filling, flexible facilities, and more.

Could FDA's ASCA program save submission time and boost pre-market testing consistency in the medical device industry?

Demystifying FDA’s ASCA on Biocompatibility for Expedited Review

Live from MD&M BIOMEDigital: Medical device manufacturers can potentially speed review by testing to recognized standards performed at accredited labs.

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5 Tips To Improve Your Remote/Hybrid Audits

Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our 'Take Five with HCP' video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.

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PDA to Collaborate with Deloitte and U.S. FDA to Improve the Quality of Compounded Drugs

Courses to cover many PDA areas of expertise, including aseptic processing.

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PDA Post-Approval Change Issues and Impacts Survey

This comprehensive survey includes data on the challenges presented by inconsistencies in how regulators treat post-approval changes and respondents’ experience with specific regulators.

Healthcare Packaging's Life Science Logistics Playbook

Healthcare Packaging's Life Science Logistics Playbook

Shipping temperature-controlled products? Get tips on preventing excursions and waste, developing a validation master plan, characterizing shipping lanes, and more.

Govzilla Announces New Customer Platform and Company Name Change to Redica Systems

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Saleable Returns Verification Delayed to 2023

Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.

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Cannabis Policy Vote May Happen by End of 2020

The MORE Act would be historic in that it would remove cannabis from the Controlled Substances Act, opening a path for regulations to follow.

Alignment 90 Sep Oct 2018

Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM)

The Agency is soliciting feedback from manufacturers on assessing and rewarding QMM through Oct. 2020. Reduced audit frequency may one day be an incentive for high performers.

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CPhI Festival of Pharma 2020 in October

Former FDA commissioner Dr. Scott Gottlieb to address industry on sustainable innovation at the two-week long event. Sessions will cover affordable medicines, supply change resiliency, AI, Vaccine production, and more.

Smithers tests med devices

Smithers, a leading provider of testing, consulting, information, and compliance services, has announced the formation of the Medical Device Testing division.

Med Devices and the FDA: Extended Deadline, Worker Safety

In extending UDI compliance dates for low-risk products, FDA cited challenges related to COVID-19. CDRH also issued recommendations for personnel safety in med device manufacturing.

FDA Commissioner Dr. Stephen Hahn

New FDA Insight Podcast on Emerging Topics

First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.

More in Regulatory

Quick Hits: Allergan is Seeking Women with Recalled Breast Implants

Allergan recalled breast implants more than 10 months ago; now they are trying to find the women who still have them.

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Quick Hits: FDA Gives Emergency Approval to Fitbit’s Ventilator

The wearable tech company developed a new ventilator to help treat the current health crisis.

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States Focus Legislation on Prescription Drug Costs

Though attention has turned to COVID-19, state legislatures were already pivoting away from last year’s opioid legislation to address drug prices—an issue that requires the Healthcare Distribution Alliance to engage across all 50 states.

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Take PDA's COVID-19 Survey in Pharmaceuticals

The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.

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Honeywell Collaborates With AI Specialist Bigfinite to Speed Medical Therapies

The collaboration will focus on helping biotech and pharma industries understand and make use of artificial intelligence and machine learning to enable faster development.

World Health Organization (WHO) declared the Wuhan coronavirus outbreak a global health emergency.

W.H.O.: Global Emergency Declared as Wuhan Coronavirus Spreads

Most of the 8,000 cases have been reported in mainland China.

Feds Say Not Legal, But Still It’s Not Rare: Why’s CBD for Sale Everywhere?

In our column’s continuing effort to correct common misconceptions about packaging law, this month we turn to cannabidiol, or CBD.

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Cannabis Packaging: Don't Fear the Reefer

UnPACKed with PMMI Podcast breaks down the latest developments in cannabis packaging as more and more states open the door to legalization.

Controversial new labeling idea

Headlines from the U.K. sound promising but reading deeper reveals very little benefit for contemplating such a major change for food manufacturers.

Activ-Blister Packaging / Image: Aptar

FDA Approves Activ-Blister™ Packaging for HIV Drug

The FDA has approved AptarGroup’s packaging solution for oral solid dose HIV prevention medicine.

Holographic foils can be used to great effect to differentiate product at the point-of-sale.

Using Holography to Fight Pharmaceutical and Healthcare Brand Piracy

Column: New trends in pharma packaging follow developments in emerging markets, demographic changes and new technologies that include holography, says chairman of the International Hologram Manufacturers Association.

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FDA Finds Asbestos in Baby Powder, Recall Ensues

Johnson & Johnson recalled thousands bottles of their famous baby powder after the FDA found trace amounts of asbestos.